Non-Cochrane · intervention · PM34400668
Efficacy of sealants and bonding materials during fixed orthodontic treatment to prevent enamel demineralization: a systematic review and meta-analysis.
Kamber R, Meyer-Lueckel H, Kloukos D, et al. · Scientific reports · 2021 · PubMed · doi:10.1038/s41598-021-95888-6
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
19
current version
GRADE rated
6
No studies
0
Included studies
24
linked below
No studies 0 · 0%Ungraded 13 · 68.4%Very low 6 · 31.6%Low 0 · 0%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
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Patients of any age receiving comprehensive/fixed orthodontic treatment with fixed appliances | 24 studies; 1117 patients (age 11-40 years); at least 12,809 teeth treated (n=24 studies) |
| Intervention | Coating material (sealant or bonding material) with or without fluoride release applied with fixed appliances | 34 different coating materials; 14 studies fluoride-releasing and 14 non-fluoride; 13 studies tested bonding materials and 11 tested sealants (n=24) |
| Comparison | Teeth with brackets without additional sealing, or teeth treated with a non-fluoride-containing material | No sealant/untreated control; non-fluoride coating materials; resin adhesive (comparator varies by comparison) |
| Outcomes | Development (initiation and progression/regression) of demineralization (WSL); primary outcome WSL by visual-tactile assessment and/or laser fluorescence (DIAGNOdent) | WSL initiation by visual-tactile assessment (all 24 studies; 19 reported presence/absence poolably); laser fluorescence/DIAGNOdent in 6 studies (not poolable) |
| Study designs | RCTs and non-randomized controlled clinical studies | 13 RCTs (11 split-mouth, 2 parallel-arm) and 11 non-RCTs (9 split-mouth, 2 parallel-arm) (n=24) |
| Timing | Not specified (no follow-up time restriction predefined) | Median follow-up 12.65 months (25th/75th percentiles 6/16.9); 7 studies ended within 6 months, 3 reported >24 months |
Search date: Not specified (no date restriction on language or year). Databases: PubMed; CENTRAL (Cochrane Central Register of Controlled Trials); Embase (plus hand-searching of reference lists of eligible studies and previous systematic reviews)
Questions and results
Sealant or coating agent (with or without fluoride release) applied to teeth with fixed appliances vs No sealant (untreated control teeth)
Population: Patients of any age (11-40 years) receiving comprehensive/fixed orthodontic treatment with fixed appliances
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
White spot lesions assessed by laser fluorescence (DIAGNOdent) White spot lesions were also measured by laser fluorescence in 3 sealant-vs-no-sealant studies, but no meta-analysis was possible due to incompatible reporting. Source: Results (paragraph on laser fluorescence) · same question in other reviews | Laser fluorescence (DIAGNOdent) was assessed in 3 studies comparing sealant vs no sealant, but meta-analysis could not be performed because results were presented parametrically or non-parametrically without the… | 3 studies | Ungraded |
Initiation of white spot lesions (WSL), visual-tactile assessment 3-27 months follow-up · Sealant without fluoride release Among non-fluoride sealants, WSL initiation was significantly reduced versus no sealant (RR 0.69); subgroup not separately GRADE-rated. Source: Fig. 3 (subgroup 1.1.2) · same question in other reviews | RR 0.69 [0.49, 0.97] | 3 studies · 847 participants | Ungraded |
Initiation of white spot lesions (WSL), visual-tactile assessment 3-27 months follow-up · Sealant with fluoride release Among fluoride-releasing sealants, the reduction in WSL initiation versus no sealant was not statistically significant (RR 0.69); subgroup not separately GRADE-rated. Source: Fig. 3 (subgroup 1.1.1) · same question in other reviews | RR 0.69 [0.46, 1.05] | 3 studies · 1467 participants | Ungraded |
Incidence of new white spot lesions by visual-tactile assessment 3 to 27 months · Overall Population: Patients receiving comprehensive fixed orthodontic treatment Sealant use reduced the incidence of new white spot lesions versus no sealant (very low certainty). Source: Figure 3; Results · same question in other reviews | RR 0.70 [0.53, 0.93] | 6 studies · 2314 participants | Very low |
Initiation of white spot lesions (WSL), visual-tactile assessment 3-27 months follow-up The additional use of a sealant probably reduces the initiation of white spot lesions during fixed orthodontic treatment compared with no sealant (RR 0.70), but the certainty of evidence is very low. Source: Abstract; Results (final para); Fig. 3; Supplementary Table S5 · same question in other reviews | RR 0.70 [0.53, 0.93] | 6 studies · 2314 participants | Very low Downgraded: risk of bias |
Fluoride-releasing compomer-based bonding agent vs Non-fluoride compomer-based bonding agent
Population: Patients of any age (11-40 years) receiving comprehensive/fixed orthodontic treatment with fixed appliances
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Initiation of white spot lesions (WSL), visual-tactile assessment 1-24 months follow-up · Compomer-based bonding agents For compomer-based bonding agents, fluoride release did not significantly change WSL initiation (RR 0.71); subgroup not separately GRADE-rated. Source: Fig. 4 (subgroup 1.2.4) · same question in other reviews | RR 0.71 [0.46, 1.11] | 2 studies · 400 participants | Ungraded |
Initiation of white spot lesions (WSL), visual-tactile assessment 1-24 months follow-up · Glass ionomer-based bonding agent For a glass-ionomer-based bonding agent (single study), fluoride release significantly reduced WSL initiation (RR 0.64); subgroup not separately GRADE-rated. Source: Fig. 4 (subgroup 1.2.3) · same question in other reviews | RR 0.64 [0.41, 0.99] | 1 study · 144 participants | Ungraded |
Initiation of white spot lesions (WSL), visual-tactile assessment 1-24 months follow-up · Resin-based sealants For resin-based sealants, fluoride release did not significantly change WSL initiation (RR 0.71, wide CI); subgroup not separately GRADE-rated. Source: Fig. 4 (subgroup 1.2.2) · same question in other reviews | RR 0.71 [0.35, 1.43] | 2 studies · 644 participants | Ungraded |
White spot lesions assessed by laser fluorescence (DIAGNOdent) White spot lesions were also measured by laser fluorescence in 3 fluoride-vs-non-fluoride studies, but no meta-analysis was possible due to incompatible reporting. Source: Results (paragraph on laser fluorescence) · same question in other reviews | Laser fluorescence (DIAGNOdent) was assessed in 3 studies comparing coating with vs without fluoride release, but meta-analysis could not be performed (results reported using incompatible continuous/categorical formats… | 3 studies | Ungraded |
Initiation of white spot lesions (WSL), visual-tactile assessment 1-24 months follow-up Fluoride-releasing coating materials do not appear to reduce WSL initiation more than non-fluoride coatings (RR 0.84, not significant); certainty of evidence is very low. Source: Abstract; Results (final para); Fig. 4; Supplementary Table S5 · same question in other reviews | RR 0.84 [0.70, 1.01] | 10 studies · 4705 participants | Very low Downgraded: risk of bias |
Initiation of white spot lesions (WSL), visual-tactile assessment 1-24 months follow-up · Resin-based bonding agents For resin-based bonding agents, fluoride release did not significantly change WSL initiation (RR 0.97); subgroup not separately GRADE-rated. Source: Fig. 4 (subgroup 1.2.1) · same question in other reviews | RR 0.97 [0.79, 1.19] | 5 studies · 3517 participants | Ungraded |
Glass ionomer cement (for bracket bonding) vs Resin adhesive (for bracket bonding)
Population: Patients of any age (11-40 years) receiving comprehensive/fixed orthodontic treatment with fixed appliances
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Initiation of white spot lesions (WSL), visual-tactile assessment 12-24 months follow-up There is no clear difference in WSL initiation between glass ionomer cement and resin adhesive for bracket bonding (RR 0.72, not significant); certainty of evidence is very low. Source: Results (final para); Fig. 5; Supplementary Table S5 · same question in other reviews | RR 0.72 [0.34, 1.54] | 3 studies · 394 participants | Very low Downgraded: risk of bias |
Fluoride-releasing coating material vs Coating material without fluoride release
Population: Patients receiving comprehensive fixed orthodontic treatment
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Incidence of new white spot lesions by visual-tactile assessment 1 to 24 months · Overall Fluoride-releasing coating material did not show a statistically significant reduction in new white spot lesions versus non-fluoride coating (very low certainty). Source: Figure 4; Results · same question in other reviews | RR 0.84 [0.70, 1.01] | 10 studies · 4705 participants | Very low |
Fluoride-releasing compomer bonding agent vs Compomer bonding agent without fluoride release
Population: Patients receiving comprehensive fixed orthodontic treatment
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Incidence of new white spot lesions by visual-tactile assessment 1 to 24 months · Compomer-based bonding agents Fluoride-releasing compomer bonding agent did not show a statistically significant reduction in new white spot lesions versus non-fluoride compomer bonding agent (very low certainty). Source: Figure 4 · same question in other reviews | RR 0.71 [0.46, 1.11] | 2 studies · 400 participants | Ungraded |
Glass ionomer cement vs Resin adhesive
Population: Patients receiving comprehensive fixed orthodontic treatment
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Incidence of new white spot lesions by visual-tactile assessment 12 to 24 months · Overall Glass ionomer cement did not show a statistically significant difference in new white spot lesions versus resin adhesive (very low certainty). Source: Figure 5; Results · same question in other reviews | RR 0.72 [0.34, 1.54] | 3 studies · 394 participants | Very low |
Comparison
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Initiation of white spot lesions (WSL), visual-tactile assessment Sensitivity (glass ionomer cement vs resin adhesive, excluding high risk-of-bias studies) | RR 1.02 [0.82, 1.27] | NR | Ungraded |
Initiation of white spot lesions (WSL), visual-tactile assessment Sensitivity (coating with vs without fluoride release, excluding parallel-arm studies) | RR 0.82 [0.66, 1.02] | NR | Ungraded |
Initiation of white spot lesions (WSL), visual-tactile assessment Sensitivity (sealant vs no sealant, excluding high risk-of-bias studies) | RR 0.85 [0.66, 1.10] | NR | Ungraded |
Initiation of white spot lesions (WSL), visual-tactile assessment Sensitivity (coating with vs without fluoride release, excluding high risk-of-bias studies) | RR 0.83 [0.67, 1.04] | NR | Ungraded |
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.
| Item | Extractor A | Extractor B | Agree |
|---|---|---|---|
| 1Research question includes PICO components | Yes | Yes | yes |
| 2Protocol established before the reviewcritical | Partial Yes | No | no |
| 3Choice of study designs explained | No | Yes | no |
| 4Comprehensive literature searchcritical | Partial Yes | Partial Yes | yes |
| 5Study selection in duplicate | Yes | Yes | yes |
| 6Data extraction in duplicate | Yes | Yes | yes |
| 7List of excluded studies with reasonscritical | Yes | No | no |
| 8Included studies described in detail | Yes | Yes | yes |
| 9Risk of bias assessed satisfactorilycritical | RCT: Yes · NRSI: Yes | NRSI: Yes · RCT: Yes | no |
| 10Funding of included studies reported | No | No | yes |
| 11Appropriate meta-analysis methodscritical | RCT: Yes · NRSI: No | NRSI: Yes · RCT: Yes | no |
| 12Impact of risk of bias on the pooled results | Yes | Yes | yes |
| 13Risk of bias accounted for in interpretationcritical | Yes | Yes | yes |
| 14Heterogeneity explained | Yes | Yes | yes |
| 15Publication bias investigatedcritical | No | N/A | no |
| 16Conflicts of interest reported | Yes | Yes | yes |
| Overall | Critically Low | Critically Low | yes |
Included primary studies 24
Open as a trial list| Study | Also included by | Outcomes it informs here | Trial PICO | Results |
|---|---|---|---|---|
| Comert 2020 Clinical effect of a fluoride-releasing and rechargeable primer in reducing white spot lesions during orthodontic treatment DOI:10.1016/j.ajodo.2019.06.013 | 1 other review | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| Hammad 2016 Efficacy of a new sealant to prevent white spot lesions during fixed orthodontic treatment DOI:10.1007/s00056-016-0052-2 | 1 other review | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| Alabdullah 2017 Effect of fluoride-releasing resin composite in white spot lesions prevention: a single-centre, split-mouth, randomized controlled trial DOI:10.1093/ejo/cjx010 | this review only | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| Alshammari 2019 Efficacy of Amorphous Calcium Phosphate (ACP) Containing Adhesive in Preventing Demineralization during Orthodontic Treatment, a Triple… DOI:10.5005/jp-journals-10024-2587 | this review only | White spot lesions assessed by laser fluorescence (DIAGNOdent) | not extracted yet | not extracted yet |
| Banks 1994 Enamel sealants: a clinical evaluation of their value during fixed appliance therapy DOI:10.1093/ejo/16.1.19 | this review only | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| Banks 1997 A clinical evaluation of the effectiveness of including fluoride into an orthodontic bonding adhesive DOI:10.1093/ejo/19.4.391 | this review only | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| Bechtold 2013 In vivo effectiveness of enamel sealants around orthodontic brackets DOI:10.1007/s00056-013-0178-4 | this review only | White spot lesions assessed by laser fluorescence (DIAGNOdent) | not extracted yet | not extracted yet |
| Benham 2009 Effectiveness of Pit and Fissure Sealants in Reducing White Spot Lesions during Orthodontic Treatment DOI:10.2319/022808-30.1 | this review only | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| Chung 1998 Fluoride release and cariostatic ability of a compomer and a resin-modified glass ionomer cement used for orthodontic bonding DOI:10.1016/s0300-5712(98)00017-7 | this review only | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| Fornell 2002 Effect of a hydrophobic tooth coating on gingival health, mutans streptococci, and enamel demineralization in adolescents with fixed… DOI:10.1080/000163502753471989 | this review only | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| Gaworski 1999 Decalcification and bond failure: A comparison of a glass ionomer and a composite resin bonding system in vivo DOI:10.1016/s0889-5406(99)70182-4 | this review only | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| Ghiz 2009 Effects of sealant and self-etching primer on enamel decalcification. Part II: An in-vivo study DOI:10.1016/j.ajodo.2007.02.060 | this review only | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| Heinig 2008 Efficacy of a Sealant DOI:10.1007/s00056-008-0741-6 | this review only | not stated | not extracted yet | not extracted yet |
| Kumar Jena 2015 Efficacy of resin-modified glass ionomer cement varnish in the prevention of white spot lesions during comprehensive orthodontic… DOI:10.1179/1465313315y.0000000005 | this review only | White spot lesions assessed by laser fluorescence (DIAGNOdent) | not extracted yet | not extracted yet |
| Leizer 2010 Efficacy of a filled-resin sealant in preventing decalcification during orthodontic treatment DOI:10.1016/j.ajodo.2008.11.025 | this review only | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| Marcusson 1997 White spot reduction when using glass ionomer cement for bonding in orthodontics: a longitudinal and comparative study DOI:10.1093/ejo/19.3.233 | this review only | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| Millett 1999 DOI:10.1043/0003-3219(1999)069<0065:dirtbb>2.3.co;2 | this review only | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| Millett 2000 DOI:10.1043/0003-3219(2000)070<0233:acctoa>2.0.co;2 | this review only | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| O'Reilly 2013 Effectiveness of a sealant compared with no sealant in preventing enamel demineralization in patients with fixed orthodontic appliances: A… DOI:10.1016/j.ajodo.2013.01.021 | this review only | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| Trimpeneers 1996 A clinical evaluation of the effectiveness of a fluoride-releasing visible light-activated bonding system to reduce demineralization… DOI:10.1016/s0889-5406(96)70112-9 | this review only | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| Tufekci 2014 Efficacy of a fluoride-releasing orthodontic primer in reducing demineralization around brackets: An in-vivo study DOI:10.1016/j.ajodo.2014.05.016 | this review only | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| Turner 1993 The Clinical Evaluation of a Fluoride-containing Orthodontic Bonding Material DOI:10.1179/bjo.20.4.307 | this review only | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| Wenderoth 1999 Effectiveness of a fluoride-releasing sealant in reducing decalcification during orthodontic treatment DOI:10.1016/s0889-5406(99)70197-6 | this review only | Initiation of white spot lesions (WSL), visual-tactile assessment | not extracted yet | not extracted yet |
| Zingler 2014 A randomized clinical trial comparing the impact of different oral hygiene protocols and sealant applications on plaque, gingival, and… DOI:10.1093/ejo/cjt043 | this review only | not stated | not extracted yet | not 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).