Evidence map›Paper›PMID 39037455›Full record

Trial reportClinical oral investigations2024

Evaluation of the remineralization potential of self-assembling peptide P11-4 with fluoride compared to fluoride varnish in the management of incipient carious lesions: a randomized controlled clinical trial.

Omar Shaalan, Karim Fawzy El-Sayed, Eman Abouauf

Registry-linked trialAbstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Clinical oral investigations, 2024. 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 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Article
  6. Review
  7. 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

3 authors.

Omar Shaalan *Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Al Saraya Str. 11, Manial, Cairo, Egypt.
Karim Fawzy El-Sayed *Oral Medicine and Periodontology Department, Faculty of Dentistry, Cairo University, Giza, Egypt.
Eman AbouaufConservative Dentistry Department, Faculty of Dentistry, Cairo University, Al Saraya Str. 11, Manial, Cairo, Egypt. e.abouauf@dentistry.cu.edu.eg.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe present trial's aim was to compare the remineralization potential of self-assembling peptide P11-4 combined with fluoride to that of fluoride varnish. MATERIALS AND

methodsTwenty-eight participants with 58 incipient carious lesions were enrolled in the present trial. Participants were randomly divided into two groups with 14 participants and 29 incipient lesions in each group. Patients were assigned either to self-assembling peptide combined with fluoride (Curodont Repair Fluoride Plus™) or sodium fluoride varnish (NaF, Bifluorid 10) groups. Both agents were applied according to the manufacturer's instructions on non-cavitated incipient carious lesions. Lesions were assessed by two calibrated and blinded assessors at baseline, and after one-, three- and six-months using a laser fluorescence device (DIAGNOdent).

resultsAlthough laser fluorescence scores significantly improved in both groups over time (p < 0.05), no notable differences were evident between both groups at one-month (p > 0.05). Yet, at three- and six-months statistically lower laser fluorescence readings were evident in the self-assembling peptide combined with fluoride group in comparison to the fluoride alone group (p < 0.05). There was 60% less risk for caries progression for Curodont Repair Fluoride Plus™ when compared to NaF varnish after six months. Self-assembling peptide combined with fluoride was able to change 65.5% of non-cavitated carious lesions from DIAGNOdent score 3 (11-20) to score 1 (0-4). Fluoride varnish was able to change 13.8% of the lesions from score 3 to score 1 after six months.

conclusionsThe self-assembling peptide combined with fluoride varnish showed higher remineralization potential than fluoride varnish alone for incipient carious lesions over a six-months follow up. CLINICAL RELEVANCE: The combination of self-assembling peptide P11-4 and fluoride could offer a new tool in managing incipient carious lesions.

Indexed as

Cariostatic AgentsDental CariesFluorides, TopicalSodium FluorideTooth RemineralizationAdultFemaleHumansMaleMiddle AgedOligopeptidesTreatment OutcomeCariostatic AgentsFluorides, TopicalOligopeptidesP11-4 peptideSodium Fluoridesodium fluoride topical preparationCariesEnamelFluorescenceFluorideIncipientLaserNon-cavitatedP11-4RemineralizationSelf-assembling peptideVarnish

Identifiers

PMID39037455
PMCPMC11263456

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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.