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Int Endodontic J - 2022 - Shah - Outcomes Reporting in Systematic Reviews On Surgical Endodontics A Scoping Review For The
Int Endodontic J - 2022 - Shah - Outcomes Reporting in Systematic Reviews On Surgical Endodontics A Scoping Review For The
DOI: 10.1111/iej.13763
REVIEW ARTICLE
© 2022 International Endodontic Journal. Published by John Wiley & Sons Ltd.
identified for PS and IR included pain, swelling, mobility and tenderness, outcomes
related to periodontal/soft tissue healing (including sinus tract), periradicular heal-
ing, tooth survival, life impact (including oral health-related quality of life), resource
use and/or adverse effects. For RR, in addition to tooth survival, endodontic com-
plications and adverse effects, the outcome measures were primarily periodontal-
related, including pocket depth reduction, attachment gain, periodontal disease and
periodontic–endodontic lesions. The majority of outcome measures for PS, IR and RR
were assessed clinically, radiologically and/or via patient history. Specific tools such
as rating scales (Visual Analog Scale, Verbal Rating Scale, Numerical Rating Scale
and other scales) were used for the assessment of pain, swelling and tenderness, and
validated questionnaires were used for the assessment of oral health-related quality
of life. The range of follow-up periods was variable, dependent on the outcome meas-
ure and the type of intervention.
Conclusions: Outcome measures, method of assessment and follow-up periods for
PS, IR and RR were identified and categorized to help standardize the reporting of
outcomes for future research studies. Additional outcome measures that were not
reported, but may be considered in the COSET consensus process, include loss of
root-end filling material, number of clinic visits, surgery-related dental anxiety and
mucogingival aesthetic-related measures, such as scarring, black triangles, root sur-
face exposure and tissue discoloration.
Registration: COMET (No. 1879).
KEYWORDS
core outcome sets, intentional replantation, periradicular surgery, root resection, scoping review,
surgical endodontics
process. Appropriate outcomes must also be chosen and leaving the crown of the tooth intact and supported by the
evaluated to minimize bias and to allow direct compari- remaining root/s (AAE, 2020). Although the indications
son of the effects of different interventions. and outcomes for PS, IR and RR may vary, their main aim
Core outcome sets (COS) are defined as an agreed is the same; to help retain teeth that have been affected by
standardized set of outcomes, which should be measured endodontic disease. In addition, with IR and RR, a biolog-
and reported as a minimum in all clinical trials on a spe- ical aspect is that the prevention of overall tooth loss is in
cific area (Core Outcome Measures in Effectiveness Trials keeping with the tissue-preserving concept.
[COMET] https://www.comet-initiative.org/; Clarke &
Williamson, 2016). The development and implementa-
tion of COS have many benefits. These include less het- MATERIALS AND METHODS
erogeneity, a reduction in the risk of reporting bias and
ensuring all trials contribute data to allow meta-analyses Protocol, registration and reporting
(Clarke & Williamson, 2016). Given the engagement of
key stakeholders, it also increases the chances that clin- The scoping review was undertaken in accordance with
ically relevant and appropriate outcomes are identified the protocol for the development of COSET (El Karim
(Webbe et al., 2018). et al., 2021), which has been registered (No. 1879) on the
The recognition of the need to promote best practice COMET website, and reported by following the Preferred
and improve treatment outcome has led to the com- Reporting Items for Systematic Reviews and Meta-
mitment by the European Society of Endodontology to Analyses extension for Scoping Reviews (PRISMA-ScR)
develop new S3- Level Clinical Practice Guidelines for guidelines (Tricco et al., 2018).
the management of pulpal and periradicular diseases
(Duncan et al., 2021a). To aid the development of these
guidelines, the outcome measures and the protocol to as- Selection criteria
sess treatment effectiveness have recently been published
(Duncan et al., 2021b). These S3-level clinical practice Studies selected for the literature search were limited to
guidelines represent a focused but limited COS since the systematic reviews and/or meta- analyses on outcomes
process was confined to the guideline steering group and of surgical endodontic procedures for permanent teeth
do not include all stakeholders, such as service users and in adult humans, with no restriction on follow-up peri-
patients. Therefore, the broader development of COS will ods, and published between January 1990 and December
benefit all stakeholders, including patients, clinicians, 2020. Records not published in the English language or
researchers, the general public, policymakers and public not available in full text were excluded. The criteria used
health professionals (El Karim et al., 2021). Undertaken (Table 1) ensured a broad literature search to cover mod-
in accordance with the protocol for the development of ern and current treatment concepts for PS, IR and RR.
Core Outcome Sets for Endodontic Treatment modalities
(COSET; El Karim et al., 2021), the aims of this scoping
review, in readiness for the subsequent consensus process, Identification of keywords
are to: (1) identify the outcomes assessed in studies eval-
uating surgical endodontic procedures, (2) report on the The keywords selected for the literature search were based
method of assessment used to measure the outcomes and on two prespecified questions with respect to treatment
(3) assess selective reporting bias in the included studies. outcome:
Although a range of procedures come under the um-
brella of surgical endodontics, most are adjunctive or not 1. Which treatment modalities can be classified under
routinely practised, and as such, there is a paucity of rel- surgical endodontics?
evant systematic reviews. Hence, this scoping review will 2. What are the variations in terminology for these
be confined to the most commonly encountered surgical interventions?
procedure in endodontics, namely PS. However, based on
a preliminary search, IR and RR were also included. IR Keywords, based on expert consensus involving three
involves intentional atraumatic tooth extraction, extra- of the authors (PKS, BSC and IEK), included the follow-
alveolar evaluation of the root surfaces, and endodon- ing: surgical endodontic treatment, endodontic surgery,
tic treatment followed by reinsertion of the tooth into endodontic microsurgery, PS, periapical surgery, apical
its original position in the extraction socket (Bender & surgery, apicectomy, apicoectomy, root-end surgery, root-
Rossman, 1993; Grossman, 1966). RR entails the surgi- end resection, tooth resection, RR, root amputation, hemi-
cal removal of the whole root and adherent soft tissues section, hemisectomy and IR.
4 | CORE OUTCOME SETS FOR SURGICAL ENDODONTICS
Information sources
RESULTS
A structured literature search was performed using
PubMed/MEDLINE, OVID, Embase, Cochrane Database Literature search
of Systematic Reviews (Cochrane) and Web of Science.
Additionally, a grey literature search was also performed The search resulted in a total of 305 records, of which 228
using Google Scholar and hand-searching of the following remained after duplicates were removed (Figure 1). After
journals: British Dental Journal, Clinical Oral Investigations, assessment of titles and abstracts, 37 records were se-
Dental Traumatology, International Endodontic Journal, lected for full-text evaluation, of which 26 systematic re-
International Journal of Oral & Maxillofacial Surgery, Journal views were selected for inclusion (Table 2; Figure 1). Kang
of Clinical Periodontology, Journal of Endodontics, Journal et al. (2015), identified during a grey literature search, was
of Oral & Maxillofacial Surgery, Journal of Periodontology, included but Salehi et al. (2019) was excluded as the full
Quintessence International, and Oral Surgery, Oral Medicine, text was not available. Del Fabbro and Taschieri (2007)
Oral Pathology, Oral Radiology & Endodontics. All searches was included as outcome rates were reported, despite the
were completed in October 2021. source of this systematic review (Del Fabbro et al., 2007)
being superseded by Del Fabbro et al. (2016).
Search process
Characteristics of studies
Depending on the database search engine used, the key-
words, relevant MeSH terms, and filters for systematic re- Characteristics of the selected systematic reviews for PS,
views and date range were blended (Table S1) to yield the IR and RR including their objectives and main findings
search results. are summarized in Tables S2-S4.
The records retrieved were collated, duplicates were re- Of the 26 systematic reviews included, 19 were on
moved, and a virtual library was created using Endnote PS. These reviews determined the outcome rate for
SHAH et al. | 5
Records excluded:
Records assessed for No outcomes measured/reported (n=5)
eligibility (n=37) Previously published records updated (n=3)
Technical paper (n=2)
Full text not available (n=1)
Systematic reviews
included (n=26)
Periradicular surgery 1. Peterson and Gutmann (2001) Grung et al. (1990) Velvart et al. (2004) Kim and Solomon (2011)
2. Del Fabbro and Taschieri (2007) Molven et al. (1991) Wang et al. (2004a) Pljevljak et al. (2011)
3. Torabinejad et al. (2009) Zetterqvist et al. (1991) Wang et al. (2004b) Song et al. (2011a)
4. Nixdorf et al. (2010) Cheung and Lam (1993) Chong and Pitt Ford (2005) Song et al. (2011b)
5. Setzer et al. (2010) Pantschev et al. (1994) Lindeboom et al. (2005a) Taschieri et al. (2011)
6. Tsesis et al. (2011) Jesslén et al. (1995) Lindeboom et al. (2005b) von Arx et al. (2011)
7. Setzer et al. (2012) Lyons et al. (1995) Payer et al. (2005) Wälivaara et al. (2011)
8. Tsesis et al. (2013) Pecora et al. (1995) Taschieri et al. (2005) Del Fabbro et al. (2012)
9. Kang et al. (2015) Danin et al. (1996) Tsesis et al. (2005) Song and Kim (2012)
10. Torabinejad et al. (2015a) Rud et al. (1996) Filippi et al. (2006) Song et al. (2012)
11. Del Fabbro et al. (2016) Rud et al. (1997) Taschieri et al. (2006) von Arx et al. (2012)
12. Ma et al. (2016) Danin et al. (1999) Tsesis et al. (2006) Kreisler et al. (2013)
13. Meschi et al. (2016) Kvist and Reit (1999) de Lange et al. (2007) Taschieri et al. (2013)
14. Chércoles-Ruiz et al. (2017) Rubinstein and Kim (1999) Peñarrocha et al. (2007) Kurt et al. (2014)
15. García-Guerrero et al. (2017) von Arx and Kurt (1999) Taschieri et al. (2007) Li et al. (2014)
16. Kohli et al. (2018) Kvist and Reit (2000) von Arx and Hänni (2007) Lui et al. (2014)
17. Alghamdi et al. (2020) Zuolo et al. (2000) Wälivaara et al. (2007) Song et al. (2014)
18. Neelakantan et al. (2020) Pecora et al. (2001) Christiansen et al. (2008) Taschieri et al. (2014)
19. Pinto et al. (2020) Rahbaran et al. (2001) Kim et al. (2008) Tortorici et al. (2014)
von Arx et al. (2001) Saunders (2008) von Arx et al. (2014)
Jensen et al. (2002) Taschieri et al. (2008a) Angerame et al. (2015)
Rubinstein and Kim (2002) Taschieri et al. (2008b) Shinbori et al. (2015)
Tobon et al. (2002) Christiansen et al. (2009) Tawil et al. (2015)
Chong et al. (2003) Del Fabbro et al. (2009) Çaliskan et al. (2016)
Dietrich et al. (2003) Shearer and McManners (2009) Kim et al. (2016)
Maddalone and Gagliani (2003) Taschieri and Del Fabbro (2009) Kruse et al. (2016)
Velvart et al. (2003) Wälivaara et al. (2009) von Arx et al. (2019)
von Arx et al. (2003) Barone et al. (2010) Truschnegg et al. (2020)
Wesson and Gale (2003) von Arx et al. (2010)
Goyal et al. (2011)
Intentional 1. Torabinejad et al. (2015b) Bender and Rossman (1993) Hayashi et al. (2004) Lee et al. (2014)
replantation 2. Mainkar (2017) Raghoebar and Vissink (1999) Abid (2010) Nizam et al. (2016)
3. Wang et al. (2020) Hayashi et al. (2002) Lee et al. (2012a) Cho et al. (2016)
Demiralp et al. (2003) Asgary et al. (2014) Jang et al. (2016)
Liying et al. (2004) Choi et al. (2014) Cho et al. (2017)
Tooth/Root resection 1. Huynh-Ba et al. (2009) Carnevale et al. (1991) Hou et al. (1999) Zafiropoulos et al. (2009)
2. Mokbel et al. (2019) Hamp et al. (1992) Svärdström and Lee et al. (2012b)
3. Setzer et al. (2019) Babay and Almas (1996) Wennström (2000) Yuh et al. (2013)
4. Dommisch et al. (2020) Basten et al. (1996) Fugazzotto (2001) Graetz et al. (2015)
Blomlöf et al. (1997) Polson and Blieden (2002) De Beule et al. (2017)
Carnevale et al. (1998) Dannewitz et al. (2006) Derks et al. (2018)
Park et al. (2009)
CORE OUTCOME SETS FOR SURGICAL ENDODONTICS
SHAH et al. | 7
Risk of bias was assessed using various methods for rand- studies included within the 26 systematic reviews. The
omized clinical trials and/or clinical studies, and selective outcome measures and related data were tabulated and
reporting bias could be determined from seven systematic classified into domains and core areas as summarized in
reviews (Table 3). Tables 4, 5 and 6 for PS, IR and RR, respectively.
Data on the outcome measures, outcome assessment The outcome of surgical endodontic treatment is depend-
method and follow-up period were extracted from the ent on several patient, operator and tooth factors; these
TABLE 3 Methods for assessing risk of bias and selective reporting bias for systematic reviews for PS, IR and RR
Periradicular surgery
Peterson and Gutmann (2001) X CS: X
Del Fabbro and Taschieri (2007) CCrob RCT: 2 low risk
Torabinejad et al. (2009) Torabinejad et al. (2007) RCT: Ø
Nixdorf et al. (2010) STROBE CS: Ø
Setzer et al. (2010) Iqbal and Kim (2007) Iqbal and Kim (2007) RCT & CS: Ø
Tsesis et al. (2011) CCrob RCT: Ø
Setzer et al. (2012) Iqbal and Kim (2007) Iqbal and Kim (2007) RCT & CS: Ø
Tsesis et al. (2013) CCrob CCrob RCT & CS: Ø
Kang et al. (2015) MJS MJS RCT & CS: Ø
Torabinejad et al. (2015a) Torabinejad et al. (2007) Torabinejad et al. (2007) RCT & CS: Ø
Del Fabbro et al. (2016) CCrob RCT: 12 low risk, 8 unclear risk
Ma et al. (2016) CCrob RCT: 6 low risk
Meschi et al. (2016) CCrob MINORS RCT: 1 low risk, 2 unclear risk
CS: 2 low risk
Chércoles-Ruiz et al. (2017) SORT SORT RCT & CS: Ø
García-Guerrero et al. (2017) CCrob ROBINS-I RCT: 3 low risk, 1 high risk
CS: 3 low risk, 3 high risk
Kohli et al. (2018) Iqbal and Kim (2007) Iqbal and Kim (2007) RCT & CS: Ø
Alghamdi et al. (2020) X X RCT & CS: X
Neelakantan et al. (2020) NOS NOS RCT & CS: Ø
Pinto et al. (2020) CCrob ROBINS-I RCT: 4 low risk
CS: 5 low risk, 1 moderate risk
Intentional replantation
Torabinejad et al. (2015b) Torabinejad et al. (2007) CS: Ø
Mainkar (2017) X CS: X
Wang et al. (2020) MINORS CS: Ø
Tooth/root resection
Huynh-Ba et al. (2009) Ø CS: Ø
Mokbel et al. (2019) Bobrowski et al. (2013) CS: Ø
Setzer et al. (2019) NOS CS: Ø
Dommisch et al. (2020) Graziani et al. (2012) CS: 2 low risk
Note: Key: RCT—randomized control trial; CS—clinical study; CCrob—Cochrane Collaboration's risk-of-bias assessment tool; MINORS—Methodological
Index for Non-Randomized Studies; MJS—Modified Jadad Scale; NOS—Newcastle Ottawa Scale; ROBINS-I—Risk Of Bias In Non-randomized Studies of
Interventions; SORT—Strength of Recommendation Taxonomy; STROBE—Strengthening the Reporting of Observational Studies in Epidemiology; Ø—not
clear; and X—not performed.
8 | CORE OUTCOME SETS FOR SURGICAL ENDODONTICS
T A B L E 4 Specific outcome measures for PS, type of outcome reported, assessment method, follow-up period and their respective
systematic reviews (Table 2)
CROM/ Systematic
Core area Outcome domain Assessment method PROM Follow-up review
Physiological/ Pain VAS PROM 3h-12 m 11, 13
Clinical VAS, VRS, NRS PROM 1-7d 11
Other scale (0–3 scale) PROM 2 h-7d 11
Verbal enquiry PROM 5d-5y 3, 10, 11, 17
OHRQoL questionnaire PROM 1-7d 11, 13, 18
Swelling Clinical assessment CROM 7d-13y 10, 11, 19
VAS PROM 1-7d 11
Other scale (0–3 scale) CROM 1-7d 11
Other scale (0–3 scale) PROM 2 h-7d 11
OHRQoL questionnaire PROM 1-7d 11, 13, 18
Verbal enquiry PROM 5-7d 11
Mobility Clinical assessment CROM 7d-5y 3, 11, 17, 19
Tenderness to percussion VAS PROM 7d-12 m 11
Clinical assessment CROM 1 m-13y 3, 11, 19
Tenderness to palpation VAS PROM 7d-12 m 11
Clinical assessment CROM 1 m-10y 3, 11, 14, 19
Sinus tract Clinical assessment CROM 0 m-13y 3, 10, 11, 14,
17, 19
Satisfactory soft tissue healing Clinical assessment CROM 4w 11
Interdental papilla height loss Clinical assessment CROM 12 m 11
Periodontal pocketing, clinical Clinical assessment CROM 1d-10y 3, 9, 11, 17,
attachment loss, apicomarginal 19
communication or dehiscence
Radiographic evidence of reduction in Radiographic assessment CROM 5y 14
periradicular lesion size (lenient
criteria)
Radiographic evidence of normal PDL Radiographic assessment CROM 1–6.5y 1, 11, 14
space (strict criteria)
Complete GBR/TCP material replacement Radiographic assessment CROM 3 m-1y 6
by new bone (strict criteria)
Healing—complete, incomplete and Clinical and radiographic CROM 6 m-10y 2, 6, 14
uncertain with no signs or symptoms assessment
(lenient criteria)
Healing—complete, incomplete, and no Clinical and radiographic CROM 0 m-11.9y 2, 3, 5, 7–17,
signs or symptoms (normal criteria) assessment 19
Clinical and CBCT CROM 12 m 11
assessment
Healing—complete, and no signs or Clinical and radiographic CROM 6 m-10y 2, 15, 17, 19
symptoms (strict criteria) assessment
Survival Tooth survival Clinical, radiographic, CROM 0 m-13y 3, 10,19
and patient history
assessment
SHAH et al. | 9
TABLE 4 (Continued)
CROM/ Systematic
Core area Outcome domain Assessment method PROM Follow-up review
Life impact Loss of tooth function Patient history assessment CROM 3 m-5y 3, 11
Bleeding Clinical assessment CROM 1-7d 11
Quality of life Validated OHRQoL PROM 1-7d 11, 13, 18
questionnaire
Difficulty with mouth opening Verbal enquiry PROM 5-7d 11
Difficulty chewing Verbal enquiry PROM 5-7d 11
Time off work Questionnaire PROM 5-7d 11
Oral awareness Verbal enquiry PROM 5-7d 11
Resource use Need for further intervention (extraction, Clinical and patient CROM 0 m-11.9y 3, 14
resurgery, tooth/root resection and/ history assessment
or interceptive non-surgical root canal
treatment)
Questionnaire PROM 5-7d 11
Need for medication (painkillers or Questionnaire PROM 3 h-7d 11
antibiotics)
Cost-effectiveness Cost-effectiveness analysis CROM 1-5y 14
Adverse effects Altered sensation or neurological damage Clinical assessment CROM 1-7d 11
categories:
paraesthesia,
hypesthesia,
anaesthesia
Clinical assessment CROM 0-2y 3
Persistent postoperative pain Clinical and patient CROM 6 m-5y 4
history assessment
Sinus membrane perforation Clinical assessment CROM 1d-12 m 3, 11, 13
Perforation of lingual or palatal cortical Clinical assessment CROM n/a 3
plate
Root perforation Clinical assessment CROM 5-7y 10
Abscess, erythema, inflammation, Clinical assessment CROM 7d-12 m 11
flare-up, suppuration or fluctuation
Other scale (0–2 scale) CROM 1-7d 11
Root fractures Clinical and radiographic CROM 1-8y 3, 10, 14
assessment
Abbreviations: CROM, clinician-reported outcome measure; PROM, patient-reported outcome measure; VAS, Visual Analogue Scale; VRS, Verbal Rating Scale;
NRS, Numerical Rating Scale; OHRQoL, oral health-related quality of life; GBR, guided bone regeneration; TCP, tricalcium phosphate; CBCT, cone-beam
computed tomography; PDL, periodontal ligament; h, hours; m, months; d, days; y, years; and w, weeks.
include operator skill, surgical site and tooth anatomy, measurement methods and follow-up period, resulting in
preoperative lesion size, and technical aspects of the sur- a lack of homogeneity.
gery (Friedman, 2005). Variation in the healing dynamics
may also be influenced by factors such as systemic health
and the biocompatibility of the materials used. Even the Quality assessment
terminology to define the outcome has an influence;
hence, the clinical outcome of surgical endodontic pro- With the exception of three systematic reviews (Del
cedures reported in the literature varies widely in terms Fabbro et al., 2016; Dommisch et al., 2020; Ma et al., 2016),
of ‘success’, ‘failure’ and ‘tooth survival’ (Cohn, 2005; many papers included were considered to be of critically
Friedman, 2005). Any disparity is further influenced low or low confidence (Table S5). Reasons include a lack
by the study design, healing criteria applied, outcome of justification for the study designs chosen for inclusion,
10 | CORE OUTCOME SETS FOR SURGICAL ENDODONTICS
T A B L E 5 Specific outcome measures for IR, type of outcome reported, assessment method, follow-up period, and their respective
systematic reviews (Table 2)
incomplete reporting (studies excluded, data extraction to variations, for example in operator skill, material and
process and funding sources), inadequacies in the applica- equipment availability, and cost-effectiveness.
tion of appropriate statistical methods for meta-analysis, The risk of selective reporting bias was not clear in the
and separate reporting of randomized and non-randomized majority of the systematic reviews where information was
clinical trials results. However, even the results of high- lacking regarding the completeness of outcomes reported,
quality reviews may have limited clinical application as and in some cases not assessed (Table 3). Risk-of-bias as-
it can be difficult to extrapolate to clinical practice due sessment tools, including selective reporting bias, were the
SHAH et al. | 11
T A B L E 6 Specific outcome measures for RR, type of outcome reported, assessment method, follow-up period and their respective
systematic reviews (Table 2)
versions of Cochrane Collaboration's risk-of-bias assess- endodontic procedures because teeth that were extracted
ment tool for randomized clinical trials, and ROBINS-I were not included, there was no breakdown for each treat-
or MINORS for clinical studies (Higgins et al., 2019; Slim ment modality. Two papers made invalid comparisons for
et al., 2003; Sterne et al., 2019). PS with other treatment modalities by using inconsistent
There may be an over-or underestimation of the healing criteria for non-surgical root canal retreatment
result for PS due to inconsistent methodology such as (Kang et al., 2015), or by assessing success for endodontic
including some studies, which did not meet less im- treatments against survival for single-crown dental im-
portant exclusion criteria (Peterson & Gutmann, 2001), plants (Chércoles-Ruiz et al., 2017).
excluding a relevant study by Kurt et al. (2014) where There was variance in the follow-up period, ranging
outcomes were reported (Chércoles-Ruiz et al., 2017), from a minimum of 6 months (Kang et al., 2015; Mokbel
and using insufficient inclusion and exclusion criteria et al., 2019; Setzer et al., 2010, 2012) to 1 year (Del Fabbro
(Alghamdi et al., 2020). Others had inconsistencies, in- et al., 2016; Del Fabbro & Taschieri, 2007; García-Guerrero
cluding partial reporting of outcome rates (Del Fabbro et al., 2017; Kohli et al., 2018; Ma et al., 2016; Peterson &
& Taschieri, 2007), the absence of any insignificant find- Gutmann, 2001; Setzer et al., 2012; Tsesis et al., 2011, 2013).
ings related to age and gender (Tsesis et al., 2013), and As 5%–25% of the previously healing cases at 1 year may
incorrectly recording the follow-up period for Rubinstein reverse within 4 years after treatment (Friedman, 2011), a
and Kim (1999) as 12, instead of 14, months (Kohli minimum follow-up period of 2 years for PS may be more
et al., 2018). Additionally, Torabinejad et al. (2009) may appropriate (Pinto et al., 2020; Torabinejad et al., 2009,
potentially have misclassified teeth during dichotomiza- 2015a). However, the risk of reporting bias in studies
tion by transforming the data for studies that did not use with longer follow-up periods is higher due to difficul-
the Rud et al. (1972) classification into a lower category; ties associated with sample monitoring (García-Guerrero
Pinto et al. (2020) reported the classification-related lim- et al., 2017).
itation by the inclusion of scar tissue healing as failure in Similar to PS, there was an over-or underestimation of
one study (Tawil et al., 2015). Furthermore, seven system- the result for IR, due to methodological and reporting inad-
atic reviews (Chércoles-Ruiz et al., 2017; García-Guerrero equacies, specifically inconsistent IR protocol (Torabinejad
et al., 2017; Kohli et al., 2018; Setzer et al., 2010, 2012; et al., 2015b; Wang et al., 2020), variable criteria for tooth
Torabinejad et al., 2015a; Tsesis et al., 2013) may have survival (Mainkar, 2017; Torabinejad et al., 2015b), in-
included studies with the same/overlapping populations correct interpretation of the survival rate (Abid, 2010),
derived from Taschieri et al. (2005, 2006, 2008a, 2013), where extractions for the failing teeth were performed at
Taschieri and Del Fabbro (2009), Song et al. (2011b, 2012, the end of the study (Torabinejad et al., 2015b), incom-
2014) and/or Song and Kim (2012). patibility of survival metrics for single-crown implants
Although Nixdorf et al. (2010) highlighted the possible and IR (Torabinejad et al., 2015b). Additionally, Wang
underestimation of the frequency of persistent pain after et al. (2020) had terminology discrepancies regarding
12 | CORE OUTCOME SETS FOR SURGICAL ENDODONTICS
‘success’ and ‘survival’, there was a failure to define the tenderness), periodontal/soft tissue healing (including
relevant outcome criteria, and there was no description of sinus tract and periodontal pocketing), periradicular heal-
quantitative statistical data analysis for the meta-analysis ing, tooth survival, resource use (need for further inter-
that was performed. vention and cost-effectiveness), life impact (loss of tooth
For RR, although a data set adjustment was performed function and bleeding) and/or adverse effects. For RR,
for Carnevale et al. (1991) to calculate tooth retention all outcome measures identified were CROMs, and these
to the last follow- up juncture, for Langer et al. (1981), included periodontal pocketing reduction/attachment
Fugazzotto (2001) and Park et al. (2009), where wider crite- gain, periodontal disease, endodontic complications,
ria for failure were used, no adjustments were made, which endodontic-periodontic lesions, tooth survival, need for
contributed to an inaccurate estimation of the survival rate further intervention and adverse effects (Table 6). CROMs
in the systematic review by Setzer et al. (2019). Furthermore, identified, but not included due to lack of coverage, were
due to heterogeneity in the study design, study population, loss of root-end filling material and number of clinic visits
survival/failure criteria, clinical assessment methods and/ (Del Fabbro et al., 2016; Pinto et al., 2020).
or follow- up periods, a meta- analysis was not possible The major limitations of CROMs include the reliance
(Dommisch et al., 2020; Huynh-Ba et al., 2009; Mokbel on subjective assessment of clinical, radiological and/or
et al., 2019); as the primary focus was on periodontics, only patient history information by the clinician, and the likely
a qualitative/descriptive analysis was performed in these misinterpretation of ‘non-healing’ cases as failures. The
three papers. Megarbane et al. (2018), a second-part retro- former can be managed by improving study design to con-
spective study following on from a first-part systematic re- trol selection and measurement bias, whereas the latter
view (Mokbel et al., 2019), reported an overall survival rate could be avoided by assessing the outcome using less sub-
of 94.8% with follow-up 5–40 years for RR, and suggested jective information from patients.
there may be inherent bias for data under 5 years, but failed Assessment methods for patient- reported outcome
to elaborate further. Although long-term survival data are measures (PROMs), depending on the outcome of interest,
important from a periodontic perspective, the investigation include the Visual Analogue Scale (VAS), Verbal Rating
of endodontic-related outcomes for RR for short, medium Scale (VRS), Numerical Rating Scale (NRS), other scales
and long follow-up periods would be useful. (0–3 rating), information from presenting complaint and
All systematic reviews identified the need for high- patient history, validated oral health-related quality of life
quality long-term clinical trials to build upon the existing (OHRQoL) questionnaires and other questionnaires (bi-
research for PS, IR and RR. The Cochrane review by Ma nary type). PROMs for PS were limited to the assessment
et al. (2016) has been superseded by Li et al. (2021), where of pain, swelling, tenderness to percussion or palpation,
two more studies were added, but the conclusion remains need for further intervention or medication, abscess/in-
largely unchanged. flammation and life impact outcome measures, including
quality of life. PROMs were reported on the assessment of
pain and need for medication only for IR, whereas none
Outcome measures were reported for RR. The respective assessment methods
and follow-up periods for these PROMs are summarized
The outcome measures identified for PS were more nu- in Tables 4 and 5. PROMs, such as assessment of surgery-
merous than those for IR or RR; this may be because related dental anxiety and mucogingival aesthetics (scar-
PS is the most commonly practised surgical endodontic ring, black triangles, root surface exposure and tissue
procedure (Gutmann, 2017). Studies on RR studies were discoloration), were not identified in the systematic re-
largely from the field of periodontics; therefore, the in- views or the relevant studies. Future research should be
terpretation of certain outcomes, for example tooth sur- directed at gathering more information from PROMs for
vival, may differ from that for endodontics; additionally, PS, IR and RR, and where possible, a patient perspective
the outcome measures identified, for example endodontic would also be useful to provide further information related
complications, were oversimplified. These discrepancies to patient experience through treatment and follow-up.
can be attributed to differences between endodontic and
periodontal treatment rationale and objectives.
There was broad coverage of clinician-reported out- Physiological/clinical outcome measures
come measures (CROMs) and their respective follow-up
period reported for PS, IR and RR (Tables 4–6). Following Discomfort-related outcome measures
clinical, radiological and/or patient history assessment,
CROMs identified for PS and IR include outcome mea- The use of rating scales, including VAS, VRS, NRS and/
sures related to discomfort (pain, swelling, mobility and or 0–3 rating, for the measurement of pain, swelling, and
SHAH et al. | 13
tenderness to percussion or palpation following PS dem- VRS, or NRS and OHRQoL questionnaire should also be
onstrated the available variation in methodology (Table 4). considered for IR and RR.
The VAS, VRS and NRS are considered reliable and vali-
dated scales (Ferreira- Valente et al., 2011; Lara-Munoz
et al., 2004), which provide specific information on the Periodontal/soft tissue healing-related
outcome measure rather than from the presenting com- outcome measures
plaint, patient history or binary-type questionnaires. As the
perception of pain, swelling and tenderness is subjective Periodontal healing-related outcome measures, including
and patients are required to translate a sensory experience absence/presence of periodontal pocketing, pocket depth
into a linear, verbal or numerical format, some individu- reduction, clinical attachment gain/loss, apicomarginal
als, for example the elderly or those with cognitive impair- communication, dehiscence, alveolar bone gain/loss, per-
ment, may find this challenging (Briggs & Closs, 1999; iodontal disease and/or endodontic-periodontic lesions,
Williamson & Hoggart, 2005). Furthermore, as rating scales were reported for PS, IR and RR (Alghamdi et al., 2020;
cannot assess improvement or deterioration, repeated as- Del Fabbro et al., 2016; Dommisch et al., 2020; Kang
sessments are required that may be subject to the ceiling et al., 2015; Mainkar, 2017; Pinto et al., 2020; Torabinejad
effect (Briggs & Closs, 1999; Williamson & Hoggart, 2005). et al., 2009, 2015b; Wang et al., 2020). Soft tissue healing-
Thus, the supplementary assessment of discomfort as part related outcome measures, including absence/pres-
of an OHRQoL questionnaire may be more helpful as it ence of a sinus tract, and satisfactory soft tissue healing,
can cover other parameters, including the worst and av- were identified for PS, including the interdental papilla
erage experience (Del Fabbro et al., 2009, 2012; Taschieri height loss (Lindeboom et al., 2005a; Velvart et al., 2003,
et al., 2014; Tsesis et al., 2005). Further information, in- 2004), and for IR (Cho et al., 2016, 2017; Choi et al., 2014;
cluding intensity, for various outcome measures may also Hayashi et al., 2002, 2004; Raghoebar & Vissink, 1999).
be collected as part of the OHRQoL questionnaire, which However, soft tissue healing-related outcome measures
uses a 5-point Likert scale to describe the different levels were not identified for RR and should be included in fu-
(Del Fabbro et al., 2009, 2012; Taschieri et al., 2014; Tsesis ture research studies.
et al., 2005); however, this also relies on subjective rating,
lacks linearity and is of low sensitivity.
In general, for PS, the literature evaluated identi- Periradicular healing-related outcome measures
fied the use of rating scales and OHRQoL questionnaire
to assess pain for up to 7 days (Del Fabbro et al., 2016; There was variation in the reporting of periradicular
Meschi et al., 2016). However, to assess the level of pain healing-related outcome measures for PS, according to
experienced, Shearer and McManners (2009) and Kurt that of Rud et al. (1972) and Molven et al. (1987). The
et al. (2014) used the VAS at 6 months and up to 1 year, reported assessment method utilized was either radio-
respectively (Del Fabbro et al., 2016). Assessment of pain logical or combined with clinical evaluation of signs
through verbal enquiry was followed up for as long as and symptoms using ‘lenient’, ‘normal’ or ‘strict’ cri-
5 years for PS (Shinbori et al., 2015; von Arx et al., 2012). teria. Based on clinical and radiological assessment
The absence/presence of swelling for PS was primarily and in the absence of signs and symptoms, ‘lenient’
assessed clinically but supplemented with further assess- criteria included ‘complete’, ‘incomplete and ‘uncer-
ment methods, including the VAS, the 0–3 rating scale tain’ healing; ‘normal’ criteria consisted of ‘complete’
(Angerame et al., 2015; Payer et al., 2005), verbal enquiry and ‘incomplete’ healing; and ‘strict’ criteria referred
and as part of an OHRQoL questionnaire. Tenderness to only to ‘complete’ healing. Most studies used the ‘nor-
percussion and palpation for PS was assessed during clin- mal’ criteria to dichotomise and analyse their result,
ical examination and with the VAS (Kurt et al., 2014). For thereby incorporating healing with scar tissue forma-
the assessment of pain following IR, the VAS was used tion (Alghamdi et al., 2020; Chércoles-Ruiz et al., 2017;
from 1 week to 2 years (Abid, 2010) and verbal enquiry Del Fabbro et al., 2016; Del Fabbro & Taschieri, 2007;
was followed up for as long as 12 years (Asgary et al., 2014; García-Guerrero et al., 2017; Kang et al., 2015; Kohli
Cho et al., 2016). Swelling, mobility, tenderness to percus- et al., 2018; Ma et al., 2016; Meschi et al., 2016; Pinto
sion and palpation were assessed clinically only for IR. et al., 2020; Setzer et al., 2010; Torabinejad et al., 2009,
Although endodontic complications and endodontic– 2015a; Tsesis et al., 2013). For radiological assessment,
periodontic lesions were reported as outcome measures the ‘lenient criteria’ required a reduction in the lesion
for RR, specific measures including pain, swelling, mobil- size (Tortorici et al., 2014), whereas the ‘strict’ criteria
ity, and/or tenderness to percussion or palpation were not required evidence of the presence of a normal periodon-
identified. In addition to these, for future studies, the VAS, tal ligament (PDL) space (Wälivaara et al., 2007), or
14 | CORE OUTCOME SETS FOR SURGICAL ENDODONTICS
the complete replacement of guided bone regeneration tooth survival to be ‘complete’, ‘incomplete’ and ‘uncer-
material or tricalcium phosphate by new bone (Tsesis tain’ healing in the absence of clinical signs and symptoms
et al., 2011). For the latter, due to the radiopacity of the based on the Molven et al. (1987) criteria, whereas Pinto
bone substitute, ‘uncertain’ and ‘incomplete’ healing et al. (2020) measured survival as tooth retention up to
cannot be reliably differentiated (Tsesis et al., 2011). the last follow-up period. Taschieri and Del Fabbro (2009)
The systematic reviews by Peterson and used asymptomatic function (Table S6; Friedman &
Gutmann (2001) and Del Fabbro and Taschieri (2007)) Mor, 2004), which included persistent periradicular radio-
used the alternative classification of Persson (1973) and lucencies that were reduced in size or unchanged, in the
Friedman and Mor (2004) for periradicular healing, re- absence of clinical signs and symptoms.
spectively (Table S6). Regarding specific studies, Kvist and Similarly, for IR there were variations when it comes to
Reit (1999) used the Reit and Grondahl (1983) classifi- defining tooth survival; these include tooth retention up to
cation, Peñarrocha et al. (2007) applied the von Arx and the last follow-up period (Bender & Rossman, 1993; Cho
Kurt (1999) classification, and Lui et al. (2014) used the et al., 2016, 2017; Demiralp et al., 2003; Lee et al., 2014;
Friedman (2005) classification, for periradicular healing Raghoebar & Vissink, 1999) or using specific survival
(Table S6). Zetterqvist et al. (1991) used their own classi- and failure criteria (Choi et al., 2014; Hayashi et al., 2002,
fication, and an updated version (Jesslén et al., 1995) was 2004; Jang et al., 2016). Hayashi et al. (2002) and Jang
used in one study (Kurt et al., 2014) where radiological as- et al. (2016) utilized their own method, and the former was
sessment was conducted by comparing preoperative and also adopted and modified by Choi et al. (2014) (Table S7).
12-month review CBCT scans. This classification, based In general, for RR, tooth retention up to the last
on the percentage reduction in the size of radiolucency, follow-up period was used to describe tooth survival
may be more relevant when comparing CBCT images in (Dommisch et al., 2020; Huynh-Ba et al., 2009; Mokbel
specific clinical situations, as currently the routine use of et al., 2019; Setzer et al., 2019) but some studies adopted
review CBCT scans cannot be justified (Patel et al., 2019). different criteria. Carnevale et al. (1991) calculated
For IR, ‘lenient’ and ‘strict’ radiological criteria, sim- tooth survival based on failure criteria, which included
ilar to PS, were reported (Abid, 2010; Asgary et al., 2014; the detection of debonded or fractured restoration, root
Jang et al., 2016). Following clinical and radiographic fracture, periodontal probing depths >5 mm, caries or
assessment, healing using ‘strict’ criteria was defined untreatable endodontic lesions. Fugazzotto (2001) con-
as ‘complete’ with no signs or symptoms and no exter- sidered the tooth to have survived if probing depths
nal root resorption/ankylosis (Cho et al., 2016; Choi were <4 mm, with no bleeding, exudation, recurrent
et al., 2014; Lee et al., 2012a; Raghoebar & Vissink, 1999). caries or root fracture, and excluded teeth that were fail-
However, there was some disagreement on what may be ing but not lost from their analysis. Park et al. (2009)
considered ‘normal’ periodontal pocket depths. Choi used the modified Langer et al. (1981) classification for
et al. (2014) and Cho et al. (2016) considered pocketing failure to determine tooth survival, which classified fail-
that was less than 5 and 6 mm, respectively, to be ‘nor- ure as: periodontal, with loss of more than 50% of al-
mal’. Based on ‘lenient’ criteria, healing was denoted as veolar bone after the first six postoperative months or
a decreased size of periradicular radiolucency with no progressive mobility; endodontic, with the development
signs and symptoms and no external root resorption/ of unrestorable root fractures or non-healing periradic-
ankylosis (Asgary et al., 2014; Cho et al., 2017; Hayashi ular areas (>1.5 mm); caries, with the presence of unre-
et al., 2002, 2004). In addition to the ‘lenient’ criteria, storable caries; and other, where strategic extraction for
Cho et al. (2017) considered the reduction in preopera- prosthesis would be necessary. However, as Carnevale
tive pocket depths; however, treatment was performed et al. (1991), Fugazzotto (2001) and Park et al. (2009)
on periodontally involved teeth with one or two preop- did not use tooth retention as the end-point to measure
erative periodontal pockets ≥6 mm. tooth survival, the failure criteria applied are of limited
No specific periradicular healing outcome measures use for endodontic purposes.
were reported for RR; instead, these were generalized
under endodontic complications. Future research should
include periradicular healing outcome measures for RR. Life impact outcome measure
taste or bad breath, with follow-up periods of 1–7 days 1998; Choi et al., 2014; Hayashi et al., 2002, 2004; Jang
(Tables 4 and 5; Del Fabbro et al., 2009, 2012; Taschieri et al., 2016; Lee et al., 2012b; Park et al., 2009; Raghoebar
et al., 2014; Tsesis et al., 2005). A simple questionnaire & Vissink, 1999; Rubinstein & Kim, 2002; Song et al., 2014;
or verbal enquiries for time off work, difficulty with Wälivaara et al., 2007; Wang et al., 2004a). Additional out-
chewing or mouth opening, oral awareness, and/or ir- come measures reported for PS include development of
ritation from sutures have also been reported for PS persistent postoperative pain, and perforation of lingual/
with follow-up periods of up to 7 days (Tables 4 and 5) palatal cortical plate, sinus membrane or tooth root (Kurt
(Christiansen et al., 2008; Kvist & Reit, 2000). CROMs et al., 2014; Nixdorf et al., 2010; Rubinstein & Kim, 2002;
based on clinical and/or patient history assessment Taschieri et al., 2014; Wang et al., 2004a).
identified include loss of tooth function for PS (Kim All adverse effect- related outcome measures were
et al., 2008; Song & Kim, 2012) and IR (Choi et al., 2014; CROMs determined during clinical, radiological and/
Hayashi et al., 2002, 2004; Jang et al., 2016; Liying or patient history assessment. Of note is the use of a
et al., 2004), and bleeding for PS (Payer et al., 2005); fol- 0–2 scale (0— none; 1— inflammation; or 2— abscess
low-up periods are reported in Tables 4 and 5. Although formation) for the differentiation and categorization of
not identified, outcome measures based on a validated abscess or inflammation, and the categorization of al-
OHRQoL questionnaire, and patients' perspectives, tered sensation, such as paraesthesia, hypesthesia and
should also be reported for IR and/or RR. anaesthesia, for PS (Payer et al., 2005). After account-
ing for measurement bias, these methods can provide
more information and are of greater relevance to their
Resource use outcome measures respective outcome measures; thus, they should also be
reported for IR and/or RR studies.
The need for further intervention, including extraction,
resurgery, RR, and/or interceptive non- surgical root
canal treatment, for PS, IR and RR, was identified as an CONC LUSIONS
outcome measure for cases deemed to have failed due
to occurrence of clinical signs and symptoms; these in- To help inform clinical decisions when planning surgi-
clude ‘uncertain’ healing for over 4 years, increased/new cal endodontic treatment and standardize the reporting
periradicular radiolucencies, external root resorption, of outcome measures in future research, the outcomes,
caries, periodontal complications or tooth/root fracture method of assessment and follow-up periods for PS, IR
(Carnevale et al., 1998; Cho et al., 2016; Choi et al., 2014; and RR were identified and categorized. Additional out-
Derks et al., 2018; Hayashi et al., 2002, 2004; Lee come measures that were not reported, but may be con-
et al., 2012b; Park et al., 2009; Raghoebar & Vissink, 1999; sidered in the COSET consensus process, include loss of
Song et al., 2014; Wang et al., 2004a; Wesson & Gale, 2003). root-end filling material, number of clinic visits, surgery-
For RR, the presence of caries, periodontal disease and related dental anxiety and mucogingival, aesthetic-related
endodontic-periodontic lesions did not necessarily lead to measures, such as scarring, black triangles, root surface
tooth loss as further restorative, periodontic and/or endo- exposure and tissue discoloration.
dontic intervention may help to retain the tooth for longer
(Zafiropoulos et al., 2009). AUTHOR CONTRIBUTION
The need for medication and cost- effectiveness, an All the authors have made substantial contributions to the
outcome measure that is based on tooth survival, were manuscript. All the authors have read and approved the
only reported for PS and IR (Chong & Pitt Ford, 2005; final version of the manuscript.
Christiansen et al., 2008; Kim & Solomon, 2011; Kvist &
Reit, 2000; Mainkar, 2017; Raghoebar & Vissink, 1999) but CONFLICT OF INTEREST
not for RR, which would be desirable in future studies. The authors have stated explicitly that there are no con-
flicts of interest in connection with this article.
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