Non-Cochrane · intervention · PM34874143

Impact of Aligners and Fixed Appliances on Oral Health during Orthodontic Treatment: A Systematic Review and Meta-Analysis.

Oikonomou Elissaios, Foros Petros, Tagkli Aikaterini, et al. · Oral health & preventive dentistry · 2021 · PubMed · doi:10.3290/j.ohpd.b2403661

Oral HealthDental cariesOrthodonticsAMSTAR 2: critically low (both extractors)
Full textEvery question was extracted from the full text, figures and supplements by two independent LLM extractors, disagreements adjudicated. Rows cite where in the review the value comes from.
Questions
20
current version
GRADE rated
7
No studies
0
Included studies
21
linked below
No studies 0 · 0%Ungraded 13 · 65%Very low 3 · 15%Low 4 · 20%Moderate 0 · 0%High 0 · 0%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Review question

ElementPlanned (methods)Found (results)
PopulationPatients undergoing orthodontic treatment (clear aligners or fixed appliances)21 studies included (882 unique records screened); 15 studies in adults (1 with chronic periodontitis), 4 in teens/adolescents, 2 mixed ages; 4 studies pooled in meta-analyses
InterventionClear/orthodontic alignersClear aligners (Invisalign in 13/21 studies; thermoformed aligners in the remainder)
ComparisonFixed appliancesFixed appliances (labial in 20/21 studies; lingual in some; self-ligating/elastomeric brackets in one)
OutcomesOral hygiene / periodontal parameters (plaque, bleeding, probing/pocket depth, gingival indices), microbiological/cariogenic parameters (S. mutans, lactobacilli) and incipient caries / white spot lesionsPeriodontal (plaque index, BOP, pocket depth, gingival index); microbiological (S. mutans, lactobacilli); caries (white spot lesions, fluorescence loss, lesion area)
Study designsRandomised controlled trials and non-randomised studies (controlled trials and observational studies); risk of bias via Cochrane RoB 2.0 (RCTs) and ROBINS-I (non-randomised)6 RCTs, 11 prospective clinical trials, 3 retrospective cohorts, 1 cross-sectional study
TimingNot restricted (any follow-up during or after orthodontic treatment)Follow-up 1-18 months (two retrospective studies covered the whole treatment duration); meta-analyses limited to <=6 months (periodontal 6-12 weeks; microbiological 3-6 months)

Search date: 31 May 2021 (updated; initial search 21 August 2020). Databases: MEDLINE via PubMed, Scopus, Cochrane Central (CENTRAL), Cochrane Database of Systematic Reviews; grey literature via ClinicalTrials.gov, OpenGrey and ISRCTN; hand-searching of retrieved full texts

Questions and results

Clear aligners (Invisalign / thermoformed aligners) vs Fixed appliances

Population: Adults undergoing orthodontic treatment
11 questions
OutcomeEffectEvidenceStatus / GRADE
Lactobacilli presence (CFU > 10^5)
3 months · Adults
Aligners probably lower the risk of high lactobacilli counts versus fixed appliances in adults at 3 months (RR 0.09, 95% CI 0.02 to 0.47; low certainty).
Source: Table 5 (Adults, lactobacilli 3 months); Fig 3 (GRADE SoF); Results · same question in other reviews
RR 0.09 [0.02, 0.47]2 studies · 140 participantsLow
Downgraded: risk of bias
Gingival index (GI)
6 to 12 weeks · Adults
A single study found no significant difference in gingival index between aligners and fixed appliances in adults at 6-12 weeks (MD -0.10, 95% CI -0.35 to 0.15; ungraded).
Source: Table 4 (Adults, GI 6-12 weeks); Results · same question in other reviews
MD -0.10 [-0.35, 0.15]1 studyUngraded
Bleeding on probing (BOP)
6 to 12 weeks · Adults
No clear difference in bleeding on probing between aligners and fixed appliances in adults at 6-12 weeks (MD -0.26, 95% CI -0.77 to 0.26; very low certainty).
Source: Table 4 (Adults, BOP 6-12 weeks); Fig 3 (GRADE SoF); Results · same question in other reviews
MD -0.26 [-0.77, 0.26]2 studies · 62 participantsVery low
Downgraded: risk of bias, inconsistency
Lactobacilli presence (CFU > 10^5)
6 months · Adults
Aligners probably lower the risk of high lactobacilli counts versus fixed appliances in adults at 6 months (RR 0.19, 95% CI 0.08 to 0.45; low certainty).
Source: Table 5 (Adults, lactobacilli 6 months); Fig 3 (GRADE SoF); Results · same question in other reviews
RR 0.19 [0.08, 0.45]2 studies · 140 participantsLow
Downgraded: risk of bias
Pocket/probing depth (PD)
6 to 12 weeks · Adults
Aligners may reduce pocket depth compared with fixed appliances in adults at 6-12 weeks (MD -0.42 mm, 95% CI -0.71 to -0.12; very low certainty).
Source: Table 4 (Adults, PD 6-12 weeks); Fig 3 (GRADE SoF); Results · same question in other reviews
MD -0.42 [-0.71, -0.12]2 studies · 62 participantsVery low
Downgraded: risk of bias
Plaque index (PI)
6 to 12 weeks · Adults
Aligners may reduce plaque index compared with fixed appliances in adults at 6-12 weeks (MD -0.58, 95% CI -0.82 to -0.34; very low certainty).
Source: Table 4 (Adults, PI 6-12 weeks); Fig 2 (forest plot); Fig 3 (GRADE SoF); Results (Effects of Interventions) · same question in other reviews
MD -0.58 [-0.82, -0.34]4 studies · 202 participantsVery low
Downgraded: risk of bias
Average fluorescence loss (dF%)
3 months · Adults
A single study reported lower average fluorescence (mineral) loss with aligners versus fixed appliances in adults at 3 months (MD -1.40, 95% CI -2.15 to -0.65; ungraded).
Source: Table 6 (Adults, average fluorescence loss 3 months); Results · same question in other reviews
MD -1.40 [-2.15, -0.65]1 studyUngraded
White spot lesions (WSLs), tooth level
3 months · Adults
A single study reported a lower risk of white spot lesions (tooth level) with aligners versus fixed appliances in adults at 3 months (RR 0.72, 95% CI 0.60 to 0.86; ungraded).
Source: Table 6 (Adults, WSLs tooth level 3 months); Results · same question in other reviews
RR 0.72 [0.60, 0.86]1 studyUngraded
S. mutans presence (CFU > 10^5)
3 months · Adults
Aligners probably lower the risk of high S. mutans counts versus fixed appliances in adults at 3 months (RR 0.07, 95% CI 0.01 to 0.49; low certainty).
Source: Table 5 (Adults, S. mutans 3 months); Fig 3 (GRADE SoF); Results · same question in other reviews
RR 0.07 [0.01, 0.49]2 studies · 140 participantsLow
Downgraded: risk of bias
S. mutans presence (CFU > 10^5)
6 months · Adults
Aligners probably lower the risk of high S. mutans counts versus fixed appliances in adults at 6 months (RR 0.22, 95% CI 0.10 to 0.51; low certainty).
Source: Table 5 (Adults, S. mutans 6 months); Fig 3 (GRADE SoF); Results · same question in other reviews
RR 0.22 [0.10, 0.51]2 studies · 140 participantsLow
Downgraded: risk of bias
Lesion area (decalcification area, pixels)
3 months · Adults
A single study reported a larger decalcification lesion area with aligners versus fixed appliances in adults at 3 months (MD 80.50 pixels, 95% CI 60.52 to 100.48; ungraded).
Source: Table 6 (Adults, lesion area 3 months); Results · same question in other reviews
MD 80.50 [60.52, 100.48]1 studyUngraded

Clear aligners (Invisalign / thermoformed aligners) vs Fixed appliances

Population: Adolescents/teenagers undergoing orthodontic treatment
9 questions
OutcomeEffectEvidenceStatus / GRADE
Plaque index (PI)
18 months · Adolescents
A single study reported lower plaque index with aligners versus fixed appliances in adolescents at 18 months (MD -0.40, 95% CI -0.77 to -0.03; ungraded).
Source: Table 4 (Adolescents, PI 18 months); Results · same question in other reviews
MD -0.40 [-0.77, -0.03]1 studyUngraded
Simplified gingival index (s-GI)
1 month · Adolescents
A single study reported lower simplified gingival index with aligners versus fixed appliances in adolescents at 1 month (MD -8.46, 95% CI -10.47 to -6.45; ungraded).
Source: Table 4 (Adolescents, s-GI 1 month); Results · same question in other reviews
MD -8.46 [-10.47, -6.45]1 studyUngraded
S. mutans presence
1 month · Adolescents
A single study found no significant difference in S. mutans presence between aligners and fixed appliances in adolescents at 1 month (RR 0.86, 95% CI 0.64 to 1.14; ungraded).
Source: Table 5 (Adolescents, S. mutans presence 1 month); Results · same question in other reviews
RR 0.86 [0.64, 1.14]1 studyUngraded
Gingival index (GI)
18 months · Adolescents
A single study reported lower gingival index with aligners versus fixed appliances in adolescents at 18 months (MD -0.57, 95% CI -0.93 to -0.21; ungraded).
Source: Table 4 (Adolescents, GI 18 months); Results · same question in other reviews
MD -0.57 [-0.93, -0.21]1 studyUngraded
White spot lesions (WSLs), patient level
9 months · Adolescents
A single study found no significant difference in white spot lesion formation (patient level) between aligners and fixed appliances in adolescents at 9 months (RR 0.33, 95% CI 0.10 to 1.04; ungraded).
Source: Table 6 (Adolescents, WSLs patient level 9 months); Results · same question in other reviews
RR 0.33 [0.10, 1.04]1 studyUngraded
Full-mouth plaque score (FMPS)
12 months · Adolescents
A single study reported a lower full-mouth plaque score with aligners versus fixed appliances in adolescents at 12 months (MD -43.48, 95% CI -47.65 to -39.31; ungraded).
Source: Table 4 (Adolescents, FMPS 12 months); Results · same question in other reviews
MD -43.48 [-47.65, -39.31]1 studyUngraded
Full-mouth bleeding score (FMBS)
12 months · Adolescents
A single study reported a lower full-mouth bleeding score with aligners versus fixed appliances in adolescents at 12 months (MD -20.44, 95% CI -22.98 to -17.90; ungraded).
Source: Table 4 (Adolescents, FMBS 12 months); Results · same question in other reviews
MD -20.44 [-22.98, -17.90]1 studyUngraded
Simplified plaque index (s-PI)
1 month · Adolescents
A single study reported lower simplified plaque index with aligners versus fixed appliances in adolescents at 1 month (MD -14.78, 95% CI -16.74 to -12.82; ungraded).
Source: Table 4 (Adolescents, s-PI 1 month); Results · same question in other reviews
MD -14.78 [-16.74, -12.82]1 studyUngraded
S. mutans counts (5th-root transformed)
1 month · Adolescents
A single study found no significant difference in S. mutans counts between aligners and fixed appliances in adolescents at 1 month (MD -2.22, 95% CI -6.82 to 2.38; ungraded).
Source: Table 5 (Adolescents, S. mutans counts 1 month); Results · same question in other reviews
MD -2.22 [-6.82, 2.38]1 studyUngraded

AMSTAR 2 appraisal

Two independent extractors rated each item. Their ratings are shown side by side because they have not been reconciled yet. The overall rating follows Shea et al. 2017: one critical flaw gives Low, more than one gives Critically Low.

ItemExtractor AExtractor BAgree
1Research question includes PICO componentsYesYesyes
2Protocol established before the reviewcriticalPartial YesPartial Yesyes
3Choice of study designs explainedNoNoyes
4Comprehensive literature searchcriticalYesYesyes
5Study selection in duplicateYesYesyes
6Data extraction in duplicateYesYesyes
7List of excluded studies with reasonscriticalNoNoyes
8Included studies described in detailPartial YesYesno
9Risk of bias assessed satisfactorilycriticalRCT: Yes · NRSI: YesNRSI: Yes · RCT: Yesno
10Funding of included studies reportedNoNoyes
11Appropriate meta-analysis methodscriticalRCT: Yes · NRSI: NoNRSI: Yes · RCT: Yesno
12Impact of risk of bias on the pooled resultsNoNoyes
13Risk of bias accounted for in interpretationcriticalYesYesyes
14Heterogeneity explainedYesYesyes
15Publication bias investigatedcriticalNoNoyes
16Conflicts of interest reportedNoNoyes
OverallCritically LowCritically Lowyes

Included primary studies 21

Open as a trial list
StudyAlso included byOutcomes it informs hereTrial PICOResults
Buschang et al. 2018
Incidence of white spot lesions among patients treated with clear aligners and traditional braces.
PMID:30556747
1 other reviewnot statednot extracted yetnot extracted yet
Dallel et al. 2020
Influence of orthodontic appliance type on salivary parameters during treatment.
PMID:33378497
1 other reviewWhite spot lesions (WSLs), patient levelnot extracted yetnot extracted yet
Karkhanechi et al. 2013
Periodontal status of adult patients treated with fixed buccal appliances and removable aligners over one year of active orthodontic…
PMID:22725616
1 other reviewPlaque index (PI)not extracted yetnot extracted yet
Levrini et al. 2015
Periodontal health status in patients treated with the Invisalign(®) system and fixed orthodontic appliances: A 3 months clinical and…
PMID:26430371
1 other reviewnot statednot extracted yetnot extracted yet
Madariaga et al. 2020
Impact of Fixed Orthodontic Appliance and Clear Aligners on the Periodontal Health: A Prospective Clinical Study.
PMID:31906577
1 other reviewnot statednot extracted yetnot extracted yet
Mummolo et al. 2020a
Salivary levels of Streptococcus mutans and Lactobacilli and other salivary indices in patients wearing clear aligners versus fixed…
PMID:32330172
1 other reviewS. mutans presence (CFU > 10^5)not extracted yetnot extracted yet
Mummolo et al. 2020b
Salivary concentrations of Streptococcus mutans and Lactobacilli during an orthodontic treatment. An observational study comparing fixed…
PMID:32250562
1 other reviewS. mutans presence (CFU > 10^5)not extracted yetnot extracted yet
Abbate et al. 2015
Periodontal health in teenagers treated with removable aligners and fixed orthodontic appliances
DOI:10.1007/s00056-015-0285-5
this review onlyFull-mouth plaque score (FMPS)not extracted yetnot extracted yet
Albhaisi et al. 2020
Enamel demineralization during clear aligner orthodontic treatment compared with fixed appliance therapy, evaluated with quantitative…
DOI:10.1016/j.ajodo.2020.01.004
this review onlyWhite spot lesions (WSLs), tooth levelnot extracted yetnot extracted yet
Azaripour et al. 2015
Braces versus Invisalign®: gingival parameters and patients' satisfaction during treatment: a cross-sectional study.
PMID:26104387
this review onlynot statednot extracted yetnot extracted yet
Chhibber et al. 2018
Which orthodontic appliance is best for oral hygiene? A randomized clinical trial
DOI:10.1016/j.ajodo.2017.10.009
this review onlyPlaque index (PI)not extracted yetnot extracted yet
Gujar et al. 2019
Cytokine levels in gingival crevicular fluid during orthodontic treatment with aligners compared to conventional labial fixed appliances:…
DOI:10.1080/00016357.2019.1607548
this review onlynot statednot extracted yetnot extracted yet
Gujar et al. 2020
Microbial profile in different orthodontic appliances by checkerboard DNA-DNA hybridization: An in-vivo study
DOI:10.1016/j.ajodo.2019.01.026
this review onlynot statednot extracted yetnot extracted yet
Han et al. 2015
A comparative study of combined periodontal and orthodontic treatment with fixed appliances and clear aligners in patients with…
PMID:26734489
this review onlynot statednot extracted yetnot extracted yet
Levrini et al. 2013
matched by author and year (probable)
this review onlyPlaque index (PI)not extracted yetnot extracted yet
Miethke & Brauner 2007
A Comparison of the Periodontal Health of Patients during Treatment with the Invisalign® System and with Fixed Lingual Appliances
DOI:10.1007/s00056-007-0655-8
this review onlynot statednot extracted yetnot extracted yet
Miethke & Vogt 2005
A Comparison of the Periodontal Health of Patients during Treatment with the Invisalign® System and with Fixed Orthodontic Appliances
DOI:10.1007/s00056-005-0436-1
this review onlynot statednot extracted yetnot extracted yet
Mulla Issa et al. 2020
Periodontal parameters in adult patients with clear aligners orthodontics treatment versus three other types of brackets: A…
PMID:32166083
this review onlynot statednot extracted yetnot extracted yet
Sifakakis et al. 2018
Salivary levels of cariogenic bacterial species during orthodontic treatment with thermoplastic aligners or fixed appliances: a…
PMID:30066184
this review onlySimplified plaque index (s-PI)not extracted yetnot extracted yet
Srinath et al. 2016
matched by author and year (probable)
this review onlynot statednot extracted yetnot extracted yet
Wang et al. 2019
Alterations of the oral microbiome in patients treated with the Invisalign system or with fixed appliances
DOI:10.1016/j.ajodo.2018.11.017
this review onlynot statednot extracted yetnot extracted yet

Overlap with other reviews

Reviews that include the same primary studies are not independent evidence. Shared counts match studies by PMID, DOI or NCT, and otherwise by author and year (a probable match).