Effect of Self-Assembling Peptide on White Spot Lesions in Orthodontic Patients: A Systematic Review and Meta-Analysis.
Shakir Sheema, Umer Farhana, Khalid Qasim, et al. · Clinical and experimental dental research · 2026 · PubMed · doi:10.1002/cre2.70321
Findings
Population Orthodontic patients with white spot lesions around fixed appliances (and extracted teeth in one in vitro study)
12 findings
| Self-assembling peptide P11-4 (alone or with fluoride or ACP) | Fluoride varnish, ACP varnish or no treatment | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) 6 weeks to 6 months · Orthodontic clinics and one laboratory study (Egypt, Germany, Turkey) · Outcome measure: fluorescence loss | SMD -1.8 [-7.49, 3.89] GRADE not reported 3 studies |
| Self-assembling peptide P11-4 (alone or with fluoride or ACP) | Fluoride varnish, ACP varnish or no treatment | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) 6 weeks to 6 months · Orthodontic clinics and one laboratory study (Egypt, Germany, Turkey) · Outcome measure: WSL score | SMD -2.13 [-4.61, 0.35] GRADE not reported 2 studies |
| Self-assembling peptide P11-4 (alone or with fluoride or ACP) | Fluoride varnish, ACP varnish or no treatment | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) 6 weeks to 6 months · Orthodontic clinics and one laboratory study (Egypt, Germany, Turkey) · Study design: RCTs | SMD -2.18 [-3.92, -0.45] GRADE not reported 5 studies |
| Self-assembling peptide P11-4 (alone or with fluoride or ACP) | Fluoride varnish, ACP varnish or no treatment | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) 6 weeks to 6 months · Orthodontic clinics and one laboratory study (Egypt, Germany, Turkey) · Risk of bias: low | SMD -1.43 [-14.11, 11.25] GRADE not reported 2 studies |
| Self-assembling peptide P11-4 (alone or with fluoride or ACP) | Fluoride varnish, ACP varnish or no treatment | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) 6 weeks to 6 months · Orthodontic clinics and one laboratory study (Egypt, Germany, Turkey) · Comparator: fluoride | SMD -1.63 [-3.65, 0.4] GRADE not reported 3 studies · 158 participants |
| Self-assembling peptide P11-4 (alone or with fluoride or ACP) | Fluoride varnish, ACP varnish or no treatment | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) 6 weeks to 6 months · Orthodontic clinics and one laboratory study (Egypt, Germany, Turkey) · Comparator: no treatment | SMD -1.85 [-3.81, 0.11] GRADE not reported 5 studies · 206 participants |
| Self-assembling peptide P11-4 (alone or with fluoride or ACP) | Fluoride varnish, ACP varnish or no treatment | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) 6 weeks to 6 months · Orthodontic clinics and one laboratory study (Egypt, Germany, Turkey) · Risk of bias: some concerns | SMD -1.8 [-3.14, -0.47] GRADE not reported 6 studies |
| Self-assembling peptide P11-4 (alone or with fluoride or ACP) | Fluoride varnish, ACP varnish or no treatment | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) 6 weeks to 6 months · Orthodontic clinics and one laboratory study (Egypt, Germany, Turkey) | SMD -1.68 [-2.71, -0.67] Very low Downgraded: risk of bias, imprecision, inconsistency, indirectness 8 studies · 395 participants |
| Self-assembling peptide P11-4 (alone or with fluoride or ACP) | Fluoride varnish, ACP varnish or no treatment | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) 6 weeks to 6 months · Orthodontic clinics and one laboratory study (Egypt, Germany, Turkey) · Sensitivity analysis: excluding the in vitro study | SMD -1.75 [-2.99, -0.53] GRADE not reported 7 studies |
| Self-assembling peptide P11-4 (alone or with fluoride or ACP) | Fluoride varnish, ACP varnish or no treatment | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) 6 weeks to 6 months · Orthodontic clinics and one laboratory study (Egypt, Germany, Turkey) · Ethnicity: European | SMD -1.43 [-14.11, 11.25] GRADE not reported 2 studies |
| Self-assembling peptide P11-4 (alone or with fluoride or ACP) | Fluoride varnish, ACP varnish or no treatment | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) 6 weeks to 6 months · Orthodontic clinics and one laboratory study (Egypt, Germany, Turkey) · Ethnicity: Asian | SMD -1.8 [-3.14, -0.47] GRADE not reported 6 studies |
| Self-assembling peptide P11-4 (alone or with fluoride or ACP) | Fluoride varnish, ACP varnish or no treatment | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) 6 weeks to 6 months · Orthodontic clinics and one laboratory study (Egypt, Germany, Turkey) · Study design: non-randomized studies | SMD -0.68 [-2.21, 0.85] GRADE not reported 2 studies |
Included primary studies 7
Open in Studies| Study | Year | Also included by | Outcomes it informs here | Trial data |
|---|---|---|---|---|
| Welk 2020 Effect of self-assembling peptide P11-4 on orthodontic treatment-induced carious lesions. PMID:32321955 | 2020 | 2 other reviews | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) | not extracted yet |
| Gohar 2023 Evaluation of the remineralizing effect of biomimetic self-assembling peptides in post-orthodontic white spot lesions compared to… PMID:36287272 | 2023 | 1 other review | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) | not extracted yet |
| Jablonski-Momeni 2020 Impact of self-assembling peptides in remineralisation of artificial early enamel lesions adjacent to orthodontic brackets. PMID:32934335 | 2020 | 1 other review | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) | not extracted yet |
| Abdel Aziz 2016 matched by author and year (probable) | NR | this review only | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) | not extracted yet |
| Ghaly 2023 Effect of self-assembling peptide and other remineralizing agents on preventing initial enamel lesions around orthodontic brackets: An in… PMID:37003059 | 2023 | this review only | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) | not extracted yet |
| Güven 2024 Remineralization of post-orthodontic white spot lesions with a fluoride varnish and a self-assembling P 11 - 4 peptides: a prospective… PMID:39096337 | 2024 | this review only | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) | not extracted yet |
| Riad 2020 matched by author and year (probable) | NR | this review only | White spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content) | 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). Only the non-Cochrane dental reviews have study lists, so overlap with Cochrane reviews is not counted yet.
Review question
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Orthodontic patients of any age and gender with WSLs associated with fixed orthodontic appliances | Orthodontic patients aged 12 to 25 years with WSLs, and extracted human teeth (in vitro) (395 participants) |
| Intervention | Self-assembling peptides | SAP P11-4 alone or combined with fluoride or ACP (n=8 studies) |
| Comparison | Fluoride varnish, CPP-ACP, placebo, untreated controls or other standard care | Fluoride varnish (n=3), no treatment (n=5), ACP varnish, CPP-ACP |
| Outcomes | Score, size or frequency of WSLs | WSL quantification: scores, lesion area, fluorescence loss, color change, mineral content, microhardness (n=8) |
| Study designs | RCTs, non-randomized clinical trials, prospective and retrospective cohort studies, in vitro studies simulating orthodontic conditions | 5 RCTs, 2 prospective non-randomized studies, 1 in vitro study |
| Timing | Not specified | 7 days to 6 months follow-up |
AMSTAR 2 items
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 | Partial Yes | yes |
| 3Choice of study designs explained | No | No | yes |
| 4Comprehensive literature searchcritical | Partial Yes | Partial Yes | yes |
| 5Study selection in duplicate | Yes | Yes | yes |
| 6Data extraction in duplicate | No | No | yes |
| 7List of excluded studies with reasonscritical | Yes | Yes | yes |
| 8Included studies described in detail | Yes | Partial Yes | no |
| 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: No · 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 | Yes | Yes | yes |
| 16Conflicts of interest reported | Yes | Yes | yes |
| Overall | Low | Low | yes |