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

NCT07431463 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-02-24

No results posted yet for this study

Summary

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.

Conditions

  • Dental Caries

Interventions

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).

OTHER

Silver diamine fluoride

Topical application of silver diamine fluoride (Riva Star, SDI, Victoria, Australia) to non-cavitated approximal carious lesions in primary teeth.

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.

Sponsors & Collaborators

  • Izmir Katip Celebi University

    lead OTHER

Principal Investigators

  • Merve Akçay, Prof. Dr. · Izmir Katip Çelebi University Faculty of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-11-30
Completion
2026-12-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07431463 on ClinicalTrials.gov