Evidence map›Paper›PMID 40715066›Full record

ArticleBDJ open2025

The remineralizing ability of self-assembling peptide P11-4, 2% arginine enriched sodium fluoride and functionalized tri calcium phosphate fluoride varnishes in treatment of white spot lesions - a randomized controlled trial.

Bardis Salah Abd Elaziz, Dina Hamdy, Mona Galal, Nagwa Mohammed Ali Khattab

Registry-linked trialAbstract read
In one paragraph

Article in BDJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07664046 (A Three-arm Randomized Controlled Trial Evaluating the Effectiveness of Self- Assembling Peptide P11-4 in the Remineralization of Enamel Carious White Spot Lesions), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07664046 narecruitingnot on this mapstarted 2026, after this paper: background citation

A Three-arm Randomized Controlled Trial Evaluating the Effectiveness of Self- Assembling Peptide P11-4 in the Remineralization of Enamel Carious White Spot Lesions

TypeinterventionalSponsorMedical University of WarsawRan2026 to 2027Enrolled75ConditionsWhite Spot Lesions on Smooth Surface of ToothArmsSelf-assembling peptide P11-4, Fluoride varnish
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Bardis Salah Abd ElazizPediatric Dentistry & Dental Public Health, Faculty of Dentistry, Modern University for Technology and Information (MTI), Cairo, Egypt. paradise19899@gmail.com.ORCID http://orcid.org/0009-0003-4616-4617
Dina HamdyPediatric Dentistry and Dental Public Health Faculty of Dentistry- Ain Shams University Cairo, Cairo, Egypt.
Mona GalalOperative Dentistry Faculty of Dentistry- Ain Shams University Cairo, Cairo, Egypt.
Nagwa Mohammed Ali KhattabPediatric Dentistry and Dental Public Health Faculty of Dentistry- Ain Shams University Cairo, Cairo, Egypt.ORCID http://orcid.org/0000-0001-6327-7910

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhite spot lesions (WSLs) is a caries lesion distinguished by white opacity due to subsurface enamel demineralization. These lesions resulting from a disparity between detrimental and protective factors and can continue to demineralize if untreated. Early diagnosis and remineralization can reverse WSLs, supporting minimally invasive dental care.

aimTo compare and assess the color of WSLs through spectrophotometer after application of Self-assembling peptide P11-4, 2% Arginine Enriched Sodium Fluoride varnish and Functionalized Tri Calcium Phosphate Fluoride varnish.

methodsThis randomized controlled triple-blind clinical trial enrolled pediatric participants (ages 8-12 years) presenting with moderate caries risk as defined by CAMBRA (Caries Management By Risk Assessment) criteria, with visible white spot lesions (WSLs) on the labial surfaces of maxillary permanent anterior teeth, classified as ICDAS scores 1 or 2. A total of 39 WSLs were incorporated into the study and randomly allocated into one of the three groups 13/each. Group I: Self-assembling peptide P11-4 varnish (study group), Group II: Arginine-enriched Sodium Fluoride varnish (study group) and Group III: Tri Calcium Phosphate Fluoride varnish (positive control group). The color change ΔE of each WSL was quantified using a spectrophotometer at the baseline. Dimensions of WSLs were assessed by digital photography, remineralizing agents were applied then patients were recalled for further applications after 3 and 6 months and for WSLs assessment after 3, 6 and 9 months.

resultsAll groups demonstrated progressive color improvement over time. At 3 months, Group I showed the least improvement (ΔE = 16.39 ± 3.04), followed by Group III (14.80 ± 3.11) and Group II (14.06 ± 4.46). By 9 months, Group II achieved (ΔE = 9.37 ± 3.79), and Group III (9.15 ± 2.74) surpassing Group I (12.21 ± 3.03). so both Group II and III ultimately outperformed Group I in color correction by the study's end. Group II achieved significantly greater WSL reduction (14.98 ± 7.55%) compared to both Group I (27.93 ± 8.98%) and Group III (22.32 ± 8.61%), with no significant difference observed between Groups I and III.

conclusionsAlthough all the three tested materials demonstrated an enhancement in the color and dimension of WSLs, 2% of Arginine Enriched Sodium Fluoride showed the best results followed by Functionalized Tri Calcium Phosphate Fluoride varnish, while self-assembling peptide P11-4 showed the lowest results.

Identifiers

PMID40715066
PMCPMC12297324

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.