Effects of Different Remineralization Agents on the Progression of Non-Cavitated Approximal Carious Lesions in Primary Teeth: A Randomized Clinical Trial (REMİN-PRİMARY)

February 23, 2026 updated by: Merve AKCAY, Izmir Katip Celebi University

Dental caries is a highly prevalent disease in children. Contemporary caries management emphasizes minimally invasive approaches that aim to arrest or reverse non-cavitated lesions rather than remove tooth structure. This randomized clinical trial aims to evaluate the effects of different remineralization agents on the progression of non-cavitated approximal carious lesions in primary teeth.

The study will be conducted in children aged 4-10 years presenting with non-cavitated approximal carious lesions in primary molars. Participants will be randomly assigned to treatment groups receiving silver diamine fluoride (SDF), a self-assembling peptide (P11-4), and/or 5% sodium fluoride (NaF) varnish. Materials will be applied according to manufacturers' instructions.

Lesion progression will be assessed using standardized bitewing radiographs obtained at baseline and follow-up visits. Radiographic evaluations will be performed by blinded investigators. In addition, potential tooth color changes associated with the treatments will be quantitatively measured using a spectrophotometer based on the CIE Lab* system at predefined follow-up intervals.

The findings of this study are expected to provide clinically relevant evidence regarding the effectiveness and aesthetic outcomes of contemporary non-invasive caries management strategies in primary teeth.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a randomized, parallel-group clinical trial investigating the effects of different remineralization agents on non-cavitated approximal carious lesions in primary teeth.

The study population will consist of children aged 4-10 years with at least two non-cavitated approximal carious lesions (radiographically classified at the enamel or outer dentin level) in primary molars. After baseline clinical and radiographic examinations, eligible teeth will receive preventive treatment interventions.

Participants will be randomly allocated to treatment groups. Interventions include silver diamine fluoride (SDF), a self-assembling peptide (P11-4), and 5% sodium fluoride (NaF) varnish. All materials will be applied following manufacturers' recommendations and standard clinical procedures. Repeat applications will be performed at scheduled follow-up visits.

Lesion progression will be evaluated using standardized bitewing radiographs taken at baseline and follow-up periods. Radiographic assessments will be performed independently by blinded examiners using predefined scoring criteria. Changes in lesion status over time will be categorized as regression, stability, or progression.

To assess potential aesthetic effects of the treatments, tooth color measurements will be performed using a spectrophotometer under standardized conditions. Color parameters will be recorded according to the CIE Lab* color system at baseline and follow-up visits.

Statistical analyses will be conducted to evaluate differences in lesion progression and color changes between treatment groups. Reliability of radiographic assessments will be evaluated using appropriate agreement statistics.

This study aims to generate clinical evidence regarding the effectiveness of minimally invasive remineralization strategies for managing non-cavitated approximal carious lesions in primary teeth.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • İzmir
      • Izmir, İzmir, Turkey (Türkiye), 35640
        • Izmir Katip Çelebi University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children aged 4-10 years
  • Presence of at least two non-cavitated proximal caries lesions in primary teeth
  • Radiographic detection of lesions classified as E1, E2, or D1
  • Absence of systemic disease
  • Cooperative patients
  • Written informed consent obtained from parents or legal guardians

Exclusion Criteria:

  • Presence of restorations on study teeth
  • Deep dentin caries (D2 or D3)
  • Cavitated lesions
  • Uncooperative patients
  • Inability to attend follow-up visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: P11-4 + NaF Varnish
Approximal carious lesions in primary teeth that were non-cavitated were treated with the self-assembling peptide P11-4, followed by 5% sodium fluoride varnish, using a randomized split-mouth design.
Other: P11-4 + NaF Varnish
Topically apply the self-assembling peptide P11-4 (Curodont Repair, Vardis, Switzerland) to non-cavitated approximal carious lesions in primary teeth, followed by 5% sodium fluoride varnish (Profluorid Varnish, VOCO, Germany).
Experimental: Silver Diamine Fluoride
This study examined the treatment of non-cavitated approximal carious lesions in primary teeth with silver diamine fluoride using a randomized split-mouth design.
Other: Silver diamine fluoride
Topical application of silver diamine fluoride (Riva Star, SDI, Victoria, Australia) to non-cavitated approximal carious lesions in primary teeth.
Active Comparator: NaF Varnish Alone
Approximal carious lesions in primary teeth that were non-cavitated were treated with 5% sodium fluoride varnish alone in a randomized split-mouth design.
Other: NaF Varnish Alone
Topical application of 5% sodium fluoride varnish (Profluorid Varnish, VOCO, Germany) was used on non-cavitated approximal carious lesions in primary teeth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic progression of approximal caries lesions
Time Frame: 6 months and 12 months after intervention
Lesion progression will be assessed using standardized bitewing radiographs and evaluated according to the E0-E2, D1-D3 radiographic scoring system. Changes in lesion status over time will be categorized as regression, stability, or progression based on predefined radiographic criteria.
6 months and 12 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth color change (ΔE)
Time Frame: 3 months, 6 months, and 12 months
Color changes will be measured using a spectrophotometer based on the CIE Lab* system. ΔE values will be calculated between baseline and follow-up visits to quantify treatment-related discoloration.
3 months, 6 months, and 12 months
Clinical lesion activity
Time Frame: 3 months, 6 months, and 12 months
Lesion activity will be assessed using a visual-tactile clinical examination according to predefined clinical activity criteria (active / inactive).
3 months, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Investigators

  • Study Chair: Merve Akçay, Prof. Dr., Izmir Katip Çelebi University Faculty of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-KAE-0126
  • 2025-TDR-DİŞF-0004 (Other Identifier: Izmir Katip Celebi University Scientific Research Projects Unit (BAP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to institutional policies and ethical considerations regarding pediatric patient confidentiality, individual participant data (IPD) will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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