Non-Cochrane · intervention · PM41747007

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 treatmentWhite 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 treatmentWhite 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 treatmentWhite 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 treatmentWhite 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 treatmentWhite 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 treatmentWhite 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 treatmentWhite 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 treatmentWhite 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 treatmentWhite 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 treatmentWhite 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 treatmentWhite 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 treatmentWhite 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
StudyYearAlso included byOutcomes it informs hereTrial data
Welk 2020
Effect of self-assembling peptide P11-4 on orthodontic treatment-induced carious lesions.
PMID:32321955
20202 other reviewsWhite 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
20231 other reviewWhite 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
20201 other reviewWhite 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)
NRthis review onlyWhite 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
2023this review onlyWhite 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
2024this review onlyWhite spot lesion quantification (score, lesion size, fluorescence loss, microhardness, color change, mineral content)not extracted yet
Riad 2020
matched by author and year (probable)
NRthis review onlyWhite 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

ElementPlanned (methods)Found (results)
PopulationOrthodontic patients of any age and gender with WSLs associated with fixed orthodontic appliancesOrthodontic patients aged 12 to 25 years with WSLs, and extracted human teeth (in vitro) (395 participants)
InterventionSelf-assembling peptidesSAP P11-4 alone or combined with fluoride or ACP (n=8 studies)
ComparisonFluoride varnish, CPP-ACP, placebo, untreated controls or other standard careFluoride varnish (n=3), no treatment (n=5), ACP varnish, CPP-ACP
OutcomesScore, size or frequency of WSLsWSL quantification: scores, lesion area, fluorescence loss, color change, mineral content, microhardness (n=8)
Study designsRCTs, non-randomized clinical trials, prospective and retrospective cohort studies, in vitro studies simulating orthodontic conditions5 RCTs, 2 prospective non-randomized studies, 1 in vitro study
TimingNot specified7 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.

ItemExtractor AExtractor BAgree
1Research question includes PICO componentsYesYesyes
2Protocol established before the reviewcriticalPartial YesPartial Yesyes
3Choice of study designs explainedNoNoyes
4Comprehensive literature searchcriticalPartial YesPartial Yesyes
5Study selection in duplicateYesYesyes
6Data extraction in duplicateNoNoyes
7List of excluded studies with reasonscriticalYesYesyes
8Included studies described in detailYesPartial Yesno
9Risk of bias assessed satisfactorilycriticalRCT: Yes · NRSI: YesNRSI: Yes · RCT: Yesno
10Funding of included studies reportedNoNoyes
11Appropriate meta-analysis methodscriticalRCT: Yes · NRSI: NoNRSI: No · RCT: Yesno
12Impact of risk of bias on the pooled resultsYesYesyes
13Risk of bias accounted for in interpretationcriticalYesYesyes
14Heterogeneity explainedYesYesyes
15Publication bias investigatedcriticalYesYesyes
16Conflicts of interest reportedYesYesyes
OverallLowLowyes