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

NCT07431463 | Active Not Recruiting

• 2 other identifiers: 2024-KAE-01262025-TDR-DİŞF-0004
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Primary Teeth, Non-cavitated Carious Lesions, Approximal Caries, Remineralization Agents, Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Radiographic progression of approximal caries lesions

  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 Outcomes (2)

• Tooth color change (ΔE)

  3 months, 6 months, and 12 months

• Clinical lesion activity

  3 months, 6 months, and 12 months

Study Arms (3)

P11-4 + NaF Varnish

EXPERIMENTAL

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

Silver Diamine Fluoride

EXPERIMENTAL

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

NaF Varnish Alone

ACTIVE COMPARATOR

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

Interventions

P11-4 + NaF Varnish OTHER

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).

P11-4 + NaF Varnish

Silver diamine fluoride OTHER

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

Silver Diamine Fluoride

NaF Varnish Alone OTHER

Topical application of 5% sodium fluoride varnish (Profluorid Varnish, VOCO, Germany) was used on non-cavitated approximal carious lesions in primary teeth.

NaF Varnish Alone

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Çelebi University Faculty of Dentistry

Izmir, İzmir, 35640, Turkey (Türkiye)

Location

Related Publications (1)

• Anusavice KJ. Present and future approaches for the control of caries. J Dent Educ. 2005 May;69(5):538-54.

  PMID: 15897335 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

silver diamine fluoride

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Merve Akçay, Prof. Dr.

  Izmir Katip Çelebi University Faculty of Dentistry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this split-mouth randomized clinical trial, the outcome assessor was blinded to the lesions' allocation to remineralization agents.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Pedodontics

Model Details: This is a randomized split-mouth clinical trial in which different remineralization agents are applied to non-cavitated approximal carious lesions in the same participants. This allows for an intra-individual comparison of the effects of the treatments.

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 24, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)