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I1945-7103-92-2-275 Clear Aligner
I1945-7103-92-2-275 Clear Aligner
ABSTRACT
Objectives: To investigate the masticatory (masticatory performance, bite force, swallowing
threshold, muscle activity, and questionnaires) and nutritional (nutrient intake) impacts of the
activation and/or installation of different orthodontic appliances (fixed labial, lingual appliances, and
clear aligners).
Materials and Methods: Six electronic databases and gray literature were searched (up to May
2021) for relevant studies evaluating mastication and nutrition after activation/installation of
orthodontic appliances. This review followed PRISMA guidelines and was registered at
PROSPERO (CRD42020199510). The risk of bias (RoB 2 and ROBINS-I) and evidence quality
Grading of Recommendations Assessment, Development, and Evaluation were analyzed.
Results: Of 4226 recorded and screened, 15 studies were finally included. Masticatory
performance (standardized mean difference [SMD]: 1.069; 95% coefficient interval [CI]: 0.619 to
1.518) and bite force (SMD: -2.542; 95% CI: 4.867 to 0.217) reduced in the first 24 to 48 hours of
fixed labial appliance installation/activation, but they were both normalized after 30 days (P . .05).
The swallowing threshold remained constant (P . .05). Nutritional intake was rarely reported but
showed copper (P ¼ .002) and manganese (P ¼ .016) reductions, with higher calorie and fat intake
(P , .05). Lingual appliances impacted chewing more than labial, and clear aligner wearers
reported fewer chewing problems (P , .001). Low to very low levels of evidence were found.
Conclusions: Based on low to very low levels of evidence, mastication was reduced during the first
24 to 48 hours of fixed labial appliance activation/installation, but it was transitory (up to 30 days).
Due to insufficient data, the nutritional impact of orthodontic appliances was not conclusive. (Angle
Orthod. 2022;92:275–286.)
KEY WORDS: Fixed orthodontic appliances; Clear aligners; Mastication; Nutrition assessment;
Systematic review
a
Graduate Student, Department of Dentistry, Federal University of Santa Catarina (UFSC), Florianópolis, Santa Catarina, Brazil.
b
Professor, Department of Dentistry, University of Alberta, Edmonton, Alberta, Canada.
c
Professor, Department of Dentistry, Federal University of Santa Catarina (UFSC), Florianópolis, Santa Catarina, Brazil.
d
Professor, Federal University of Lavras (UFLA), Lavras, Minas Gerais, Brazil.
Corresponding author: Dr Thais M. S. V. Gonçalves, Department of Dentistry, Federal University of Santa Catarina (UFSC), Av.
Delfino Conti, s/n, Trindade, Florianópolis, SC 88040-900, Brazil
(e-mail: [email protected])
Accepted: October 2021. Submitted: June 2021.
Published Online: December 8, 2021
Ó 2022 by The EH Angle Education and Research Foundation, Inc.
chewing hard and consistent food, adopting a soft diet Information Sources and Search
as described in previous treatment studies.4
Searches in the following databases started in
Different orthodontic modalities are now available
August 2020 with the last update performed in May
beside conventional fixed labial appliances, including
2021: Cochrane Library, EMBASE, Latin American and
lingual appliances and clear aligners. However, little
Caribbean Health Sciences (LILACS), PubMed (in-
evidence exists on how each orthodontic treatment
cluding Medline), SCOPUS, and Web of Science
would affect mastication.3,4 A recent review5 reported
(Supplemental Table 1). Gray literature was also
that patients using fixed lingual appliances would be
searched (Google Scholar, Open Grey, and ProQuest).
more likely to suffer from eating difficulty than those
with labial appliances. In contrast, patients using A hand search on the reference lists of included
clear aligners reported fewer chewing limitations than studies was also performed (Figure 1). No language,
those using fixed labial devices.6 With increasing publication time, or follow-up period restrictions were
interest in esthetic and digitally guided dental applied. The reference manager EndNote (version X9,
procedures such as clear aligners, it is important to Clarivate, Philadelphia, PA, USA) collected references
evaluate the functional impact of these new treatment and removed duplicates.
modalities. The study selection was independently conducted
Orthodontic patients also reported taste changes in a two-phase process. In phase one, titles and
and that it took a longer time for eating.7 Chewing abstracts that did not fulfill eligibility criteria were
difficulties may be caused by orthodontist advice to excluded. In phase two, full texts of the remaining
avoid certain foods, fear of breakage, and even social studies were evaluated (Supplemental Table 2). The
embarrassment.7 Taken together, these factors may entire process was conducted by two calibrated
contribute to food restrictions and lead to nutritional authors (LD and APB) using Rayyan.9 Any dis-
problems. However, studies evaluating nutritional agreement was solved with the coordinator
changes during orthodontic treatment are scarce and, (TMSVG).
to date, the reliability of this evidence has not been
critically assessed. Therefore, this systematic review Data Extraction and Risk of Bias
aimed to investigate the masticatory and nutritional Two independent reviewers (LD and APB) per-
impact of the installation and/or activation of different formed data extraction using spreadsheets (Excel
orthodontic appliances (fixed labial and lingual appli- v.16.49, Microsoft, Redmond, WA, USA). The authors,
ances, and clear aligners) to answer the focused year of publication, study design, country, sample size,
question: ‘‘How does the activation and/or installation gender, age of participants, type of orthodontic
of different orthodontic appliances affect the mastica- appliance, follow-up time, and outcomes were obtained
tory function and nutrition of patients?’’ from the included studies (Table 1). To retrieve any
pertinent unreported information, the authors made up
MATERIALS AND METHODS
to three attempts to contact corresponding authors. For
Protocol and Registration mastication assessment, the masticatory performance,
bite force, swallowing threshold, and masticatory
This systematic review was reported according to muscle activity were considered as main outcomes;
updated PRISMA guidelines.8 The study protocol was whereas, for the nutritional assessment, the nutrient
registered at PROSPERO under the registration intake, risk of malnutrition, blood nutrient levels, and
number CRD42020199510. body mass index were the main outcomes considered
in the analysis.
Eligibility Criteria The risk of bias was independently analyzed by two
The PICO (Patient/Problem, Intervention, Compari- reviewers (APB and LJP). The coordinator (TMSVG)
son, Outcome) strategy was applied. Randomized and was involved in solving disagreements. To evaluate
non-randomized controlled clinical trials, as well as the risk of bias of the randomized controlled trials
before and after studies, performed in adults and (RCTs), the revised Cochrane Collaboration tools RoB
adolescents (P), undergoing different orthodontic 210 were applied. The Intervention tool ROBINS-I11 for
treatments (I) comparing the mastication and nutrition non-randomized studies, specifically considering the
(O) between baseline and a period after the activation before and after design, was applied in the remaining
or installation of appliances were selected. Studies studies. For each domain, the risk of bias was judged
reporting data from partially edentulous patients, case as ‘‘low risk,’’ ‘‘unclear risk,’’ and ‘‘high risk.’’12 The Risk-
series, animal models, reviews, and noncontrolled of-bias VISualization (robvis) tool was used to sum-
studies were excluded. marize data.
Table 1. Continued
Mean Age 6 Follow-Up Time
Standard (Before
Author, Year Experimental Deviation and After Mastication Nutrition Pain After Main
(Country) Study Design Groups (N) (Years) Installation) Outcomes Outcomes Activation Conclusions
Lou et al., Non- Clear Aligner 35.3 6 17.6 Baseline EGM Masseter N/A N/A Clear aligner therapy
202124 randomized (n ¼ 17) 1, 2, 3, and 4 wk produces a transient
(Canada) clinical trial increase in masseter
(before-after muscle activity within the
study) first 2 wk of treatment and
decreases towards baseline
thereafter.
Magalhães et Non- Fixed labial 21.1 6 10.4 Before (T0) Masticatory N/A VAS (mm) Masticatory performance is
al., 20144 randomized appliance (n Immediately (T1) performance (X50) 10.9 6 17.2 (T0) reduced, and the swallowing
(Brazil) clinical trial ¼ 27) 48 h (T2) 5.6 6 1.0 (T0) 22.5 6 20.3 (T1) threshold for harder foods is
(before-after 1 mo (T3) 5.9 6 1.1 (T1) 52.7 6 34.4 (T2) increased at the peak of
study) 3 mo (T4) 7.5 6 2.8 (T2) 17.8 6 22.9 (T3) orthodontic pain (48 h after
5.9 6 1.4 (T3) 7.4 6 15.5 (T4) archwire placement). At
5.9 6 1.5 (T4) long-term follow-up
Swallowing threshold examination, masticatory
(X50) and swallowing
4.6 6 1.3 (T0) performances return to
4.5 6 1.2 (T1) those observed before the
5.6 6 3.2 (T2) appliance placement.
4.5 6 1.5 (T3)
4.2 6 1.1 (T4)
Swallowing threshold
(number of cycles)
34.2 6 14.7 (T0)
30.6 6 11.4 (T1)
34.4 6 13.4 (T2)
32.2 6 12.4 (T3)
32.4 6 13.5 (T4)
Mansor et al., Non- Fixed labial 17.8 6 3.1 Before (T0) OHIP-16 (Eating N/A OHIP-16 OHRQoL deteriorates 24 h
201218 randomized appliance (n 24 h (T1) avoidances) 2.0 6 0.8 (T0) after insertion of fixed
(Malaysia) clinical trial ¼ 60) 1.8 6 1.0 (T0) 3.5 6 1.2 (T1) orthodontic appliances, with
(before-after 4.2 6 1.0 (T1) significant impact over the
study) masticatory capacity.
Prema et al., Non- Fixed labial N/A Baseline (T0) Bite Force (N) N/A N/A Bite force is reduced to 50%
201919 randomized appliance (n 1 wk (T1) 469.4 6 69.2 (T0) of the pretreatment level
(India) clinical trial ¼ 30) 1 to 6 mo (T2–T7) 191.7 6 62.9 (T1) during the first week of fixed
(before-after 230.6 6 60.9 (T2) labial appliance. After
study) 257.3 6 42.4 (T3) aligning and leveling stage,
306.6 6 52.2 (T4) the bite force reaches the
320.6 6 48.1 (T5) baseline level in
343.9 6 42.8 (T6) hyperdivergent treatment
389.2 6 38.6 (T7) group, while it reaches
close to pretreatment level
in hypodivergent and
normodivergent treatment
groups.
Riordan et al., Non- Fixed labial 12–16 y Baseline (T0) N/A 3 days-dairy N/A It may be beneficial to provide
199720 randomized appliance (n 72 h (T1) Cooper nutritional guidance to
(USA) clinical trial ¼ 10) 1.23 6 0.61 (T0) orthodontic patients to
(before-after 0.85 6 0.69 (T1) increase the copper and
study) (P ¼ .002) manganese content of the
Manganese diet. Further research with a
2.85 6 1.63 (T0) larger sample size would
2.08 6 2.06 (T1) uncover the magnitude of
(P ¼ .016) the effects of orthodontic
Calories from fat treatment on nutrient intake.
49.32% to
55.54%
Calories from
carbohydrates
36.71% to
32.14%.
Table 1. Continued
Mean Age 6 Follow-Up Time
Standard (Before
Author, Year Experimental Deviation and After Mastication Nutrition Pain After Main
(Country) Study Design Groups (N) (Years) Installation) Outcomes Outcomes Activation Conclusions
Trein et al., Non- Fixed labial 17.3 6 5.2 Baseline (T0) Masticatory N/A VAS (mm) Masticatory performance of
20133 randomized appliance (n 24 h (T1) performance (X50) 0.60 6 0.70 (T0) orthodontic patients
(Brazil) clinical trial ¼ 10) 1 mo (T2) 7.01 6 2.9 (T0) 66.2 6 34.5 (T1) significantly reduces 1 d
(before-after 10.2 6 1.1 (T1) 3.20 6 3. (T2) after installation and
study) 6.8 6 1.3 (T2) activation of fixed labial
Swallowing threshold appliance appliances. This
(X50) period represents the peak
5.5 6 2.4 (T0) time of orthodontic pain,
6.2 6 2.1 (T1) which tends to decrease
5.9 6 2.4 (T2) with time with consequently
Swallowing threshold recovery of the mastication.
(number of cycles)
26.7 6 9.1 (T0)
31.4 6 13 (T1)
23.3 6 10.5 (T2)
White et al., Randomized Clear Aligner N/A Baseline (T0) Difficult in chewing N/A N/A Immediately after appliance
201723 clinical trial (n ¼ 23) Day 1(T1) (VAS – mm) placement, fixed labial
(USA) Fixed labial Day 2 (T2) T0 - NS appliances produced more
appliance (n Day 3(T3) T1 - NS discomfort while chewing
¼ 18) Day 4 (T4) T2 – NS than did clear aligners. By
Day 5 (T5) T3 – clear , labial day 7, patients in the aligner
Day 6 (T6) (P ¼ .04) group experienced minimal
Day 7 (T7) T4 - clear , labial discomfort, consistently less
(P ¼ .03) than baseline discomfort.
T5 – clear , labial
(P ¼ .04)
T6 – clear , labial
(P ¼ .01)
T7 - clear , labial
(P ¼ .008)
Wu et al., Non- Fixed labial Fixed labial 1 to 12 wk VAS (mm) VAS (mm) N/A Regarding impact on
201122 randomized appliance (n appliance 1 mo Difficult in chewing – Dietary changes mastication, there was no
(Hong Kong) clinical trial ¼ 30) (20.3 6 4.2) 3 mo labial vs lingual – – labial , significant difference
(before-after Fixed lingual Fixed lingual NS lingual – (P , reported in biting or chewing
study) appliance (n appliance Difficult in biting – .001) between patients treated
¼ 30) (21.6 6 2.2) labial vs lingual – Avoidance of with labial and lingual
NS eating out - orthodontic appliances. Oral
Difficult in labial , lingual impact disturbances were
swallowing – labial – (P , .001) most common in the early
, lingual (P , phase of treatment. By the
.05) end of 3 mo, oral impacts
were comparable for those
treated with labial and
customized lingual
appliances.
Mastication was objectively assessed by masticatory sessed through self-reported questionnaires. No serious
performance (X50),3,4,15,16 swallowing threshold (particle problems were detected in the remaining domains
size and number of cycles),3,4,17 maximum bite force,14,19 (Figure 2A). For the non-randomized studies (before
masseter muscle electromyography,17,24 subjective mas- and after design), the risk of bias was considered low in
tication (visual analogue scale of 10 cm),22,23 and four studies,4,14,16,19 moderate in three,3,15,24 and serious in
questionnaires.6,18,21,25 Only one study20 reported data the remaining six studies.6,17,18,29,22,25 In the first domain,
regarding nutritional assessment before and after the bias was considered serious6,18,22,25 or moderate3,15,20 due
activation of a fixed labial appliance (3-day diet diary). to confounding factors or small sample size. A poor
description of patient eligibility criteria was also consid-
Risk of Bias ered.3,4,6,14–18,20,22,24,25 Intervention bias was considered
The risk of bias of individual studies is summarized in moderate in three studies,15,17,20 due to the poor
Figure 2 and Supplemental Tables 4 and 5. The description of eligibility criteria and patient selection.
RCTs21,23 presented serious risk only for outcome One study6 used a retrospective design, increasing its
measurements since mastication was subjectively as- risk of bias. Deviations of intended interventions were
Table 2. Results of Quality Assessment of Studies Included in Meta-Analyses (The Grading of Recommendations Assessment, Development
and Evaluation – GRADE)
Certainty Assessment
N8 of Risk
Outcome Studies Study Design of Bias Inconsistency Indirectness Imprecision Others Certainty
Masticatory Performance 3 Before-after studies seriousa
serious b
not serious seriousc
none ***
VERY LOW
Swallowing Threshold 2 Before-after studies not serious not serious not serious very seriousc none **
(particle size) LOW
Swallowing Threshold 2 Before-after studies not serious not serious not serious very seriousc none **
(n8 of cycles) LOW
Bite Force 2 Before-after studies not serious very seriousd not serious very seriousc none ***
VERY LOW
a
Risk of bias due to confounding, since inclusion criteria for patients of two of the included studies was not properly described.
b
Significant heterogeneity (I2 ¼ 78%) between studies at 24 h 3 30 d comparisons.
c
Sample size of , 400 participants among included studies.
d
High heterogeneity (I2 ¼ 94%) between studies.
considered low due to the short period of evaluation (24 (Figure 3A). Comparing baseline to 30 days, differenc-
hours to a month). No patients required changes in es were no longer observed (Figure 3B), and mastica-
interventions. Only one study25 excluded patients for not tion was recovered entirely after 30 days of the
answering the questionnaire correctly. As for outcome activation (Figure 3C). The swallowing threshold was
measurement bias, four articles6,17,22,24 presented moder- also analyzed by two studies3,4 (Supplemental Table
ate risk due to the lack of blinding or patient self- 3). No particle size changes were observed, and the
assessment, leading to erroneous results if instructions number of masticatory cycles remained constant when
and training were not correctly delivered. Since the comparing baseline to 48 hours or 30 days of fixed
remaining 11 studies3,4,14–16,18–21,23,25 evaluated only one appliance activation (P . .05) (Figure 4). In contrast,
intervention, blinding outcome assessors would not have maximum bite force was significantly reduced 1 week
been possible; therefore, the risk of bias was judged as after fixed labial appliance activation (SMD: 2.542,
low. No issues were detected in the reported results; 95% CI: 4.867 to 0.217, P , .032) (Figure 5). Only
thus, all studies were considered at low risk. one study20 reported nutritional outcomes before and
after fixed labial appliance activation. Significant intake
Level of Evidence reduction of copper (P ¼ .0018) and manganese (P ¼
.016) were observed 3 days after activation. Increased
The GRADE evaluation of the included studies
total calories and saturated fat consumption (49.32% to
resulted in low and very low results (Table 2).
55.54%) was also observed, while the percentage of
Inconsistency was judged to be serious to very serious,
calories from carbohydrates (36.71% to 32.14%)
and the risk of bias was deemed as not serious since
decreased.
the paired design reduced the influence of confounding
Only three studies21,22,25 reported masticatory out-
factors. Significant heterogeneity between studies (I2 .
comes of patients using fixed lingual appliances, and
50%) rendered serious to very serious limitations to
two of them compared lingual to labial appliances.21,22
judgment for mastication. As for indirectness, none of
However, none of them performed objective assess-
the outcomes presented issues regarding applicability.
ments of mastication, jeopardizing further analysis due
Thus, they were judged as presenting no serious
to high methodological heterogeneity. A moderate to
limitations. Imprecision was considered serious for all
severe impairment on mastication was reported imme-
outcomes due to the small number of patients (,400),
diately after lingual bracket placement.21,22 Patients
limiting effect size measurements.
treated with lingual appliances reported more discom-
fort, dietary changes, swallowing difficulties, speech
Results of Individual Studies
disturbances, and social problems than those with
Studies comparing the masticatory performance of labial appliances.22 No significant differences were
fixed labial appliances presented homogeneous meth- found in oral self-care and patient satisfaction;22
ods (Supplemental Table 5). Thus, meta-analyses however, patients from the lingual group were not yet
were performed comparing the chewed particle size completely satisfied with their masticatory ability.21,25
(X50) (Figure 3). A significant particle size reduction Three studies6,23,24 evaluated patients using clear
was observed after 24 hours of activation (SMD: 1.069; aligners and two of them6,23 compared clear aligner
95% coefficient interval [CI]: 0.619 to 1.518, P , .0001) wearers to fixed labial appliance patients. Similarly,
Figure 2. Risk of bias summary of reviewer judgments about each risk of bias item according to the different study designs. (A) Risk of bias
assessment for randomized clinical trials (ROB 2.0 tool); (B) Risk of bias assessment for Nonrandomized studies (ROBINS-I tool).
these studies evaluated only subjective mastication6,23 restrictions (P ¼ .02), and less mucosal ulcerations (P ¼
and muscle electromyography (EMG),24 impairing .01).6 No significant differences in swallowing threshold
further data analysis. Masseter muscle EMG increased were found between clear aligner and fixed appliance
just after the installation or activation of clear aligners.24 groups.6
However, these changes were transitory and, after 2
weeks, muscle activity returned to baseline levels.24 DISCUSSION
Compared to clear aligner wearer, patients using fixed In this review, masticatory performance (X50) was
labial appliances reported greater masticatory discom- significantly reduced after 24 hours of fixed labial
fort, especially after installation or during the first 2 appliance activation. Similarly, a significant reduction
months of treatment.6 Patients using clear aligners of bite force was also observed 1 week after fixed labial
reported better chewing ability (P , .001), no food appliance activation. However, after 30 days, mastica-
Figure 3. Forest plots of masticatory performance (X50) after the activation of fixed labial appliances; (A) Comparisons between baseline and 24
hours of activation; (B) Comparisons between baseline and 30 days of activation; (C) Comparisons between 24 hours and 30 days of activation).
tory performance and bite force were fully recovered. initial bonding of appliances, greater deflection of the
On the other hand, the swallowing threshold was not archwires to obtain bracket engagement may lead to
compromised by appliance activation. Nutritional eval- greater pain, consequently affecting bite force.29 In
uations were limited but indicated a reduction in copper addition, the pain symptoms are higher in the first 48
and manganese levels. Similar results were previously hours after installation, reducing bite force and
reported, especially regarding masticatory perfor- masticatory performance.
mance.3,4,16 Masticatory impairment might be related Dietary changes are commonly reported by patients
to an acute inflammation process and/or pain symp- using orthodontic appliances. However, in this review,
toms, which generally occur 24 to 48 hours after only one study20 reporting nutritional outcomes was
activation. However, subjects with poor mastication did found, preventing further analysis, but showing that
not use more strokes to chew food (eg, did not copper and manganese blood levels apparently
increase the swallowing threshold), but usually swal- decreased.20 Copper is essential for hemoglobin
lowed larger particles.4,26 Thus, progressive tooth formation and iron transport for red blood cell
movement and temporary pain may not have been production.30 At the same time, manganese plays a
strong enough to cause swallowing interferences. crucial role in bone remodeling and glucose metabo-
Reductions in bite force were also expected since bite lism.30 Deficiencies of these nutrients are linked to
force is one of the most critical factors of masticatory anemia, neutropenia, bone disease, reproductive
performance variability (R2 ¼ .55, P , .001)27 and problems, and impaired glucose tolerance.31 Rich
because bite force reduction can be related to transient copper and manganese sources include shellfish,
occlusal changes or periodontal mechanoreceptor organ meats, nuts, whole grains, and raw vegetables.
sensibility.14,19 Occlusal changes explained 10%–20% These are types of food which are commonly avoided
of maximum bite force variation in adults.28 Just after by orthodontics patients. Increased total calories and
Figure 4. Forest plots of swallowing threshold (particle size and the number of cycles) after the activation of fixed labial appliances. (A)
Comparisons between baseline and , 48 hours; (B) Comparisons between baseline and 30 days of activation; (C) Comparisons between
baseline and , 48 hours; (D) Comparisons between baseline and 30 days of activation.
Figure 5. Forest plots of bite force comparisons before and 1 week after the activation of fixed labial appliances.
saturated fat levels were also observed after activation Due to insufficient data, the nutritional impact of
of fixed labial appliances, with reduced carbohydrate orthodontic appliances was not conclusive.
intake.20 Consistent with these findings, Shirazi et al.32 Future evidence from well-designed studies is
showed a greater intake of fat and cholesterol and a necessary to better understand the impacts of clear
lower intake of fiber, chromium, and beta-carotene in aligners and lingual appliances.
orthodontic patients. A high-fat diet is associated with
obesity, increased risk of hypertension, cardiovascular ACKNOWLEDGMENTS
disease, atherosclerosis, and noninsulin-dependent
diabetes.33 On the other hand, nutritional changes The authors would like to acknowledge the assistance of the
librarian Goreti M. Savi from the Federal University of Santa
depend on several factors and are not automatically
Catarina. This work was financed in part by CAPES
linked to masticatory improvement or impairment. (Coordena ção de Aperfeiçoamento de Pessoal de Nı́vel
Surprisingly, although orthodontic patients report eat- Superior) for supporting academic and professional
ing difficulties, some of them also reported healthier development.
eating habits.34 Nevertheless, further research is
encouraged to analyze long-term nutritional changes SUPPLEMENTAL DATA
during orthodontic treatment.
Supplemental Tables available online.
Lingual fixed appliances are a good alternative for
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