Effect of Silver Diamine Fluoride and LED Activation on Residual Caries Activity in Class II Cavities

NCT07250009 | Completed

• 1 other identifier: CanakkaleOMU3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This observational clinical study investigates the effect of silver diamine fluoride (SDF) and its activation with light-emitting diode (LED) on residual caries activity after caries excavation in Class II primary molar cavities. Dental caries in children remains highly prevalent worldwide, and conventional restorative treatments can be difficult in young or uncooperative patients. Minimally invasive approaches such as Atraumatic Restorative Treatment (ART) often leave softened dentin near the pulp, which may remain metabolically active. SDF has been introduced as a simple and effective agent for caries arrest due to its antibacterial and remineralizing effects. However, its optimal application protocol is still under investigation. Recent studies suggest that LED light exposure after SDF application may enhance its mineralizing effect by accelerating silver ion precipitation, though clinical data remain limited. This study aims to compare the short-term impact of SDF alone and SDF with LED activation on residual caries activity measured quantitatively with the DIAGNOdent laser fluorescence device. The study will include healthy, cooperative children aged 4-9 years with Class II carious lesions in primary molars. After caries excavation, cavities will receive either SDF alone or SDF followed by 20 seconds of blue LED light (470 nm, 1000-1200 mW/cm²). Residual caries activity will be recorded immediately after application and after one week. The primary outcome is the change in DIAGNOdent readings between groups, while secondary analyses will consider factors such as cavity size, tooth type, and location. The study seeks to clarify whether LED activation enhances the caries-arresting potential of SDF and contributes to evidence-based, minimally invasive strategies in pediatric dentistry.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Change in residual caries activity measured by DIAGNOdent laser fluorescence

  Residual caries activity in Class II primary molar cavities will be quantitatively assessed using the DIAGNOdent laser fluorescence device (KaVo, Germany). The DIAGNOdent readings (0-99 scale) reflect the fluorescence of carious dentin; higher values indicate greater caries activity. The mean of three consecutive readings per site will be recorded. The primary outcome is the change in DIAGNOdent value from D₁ to D₃, comparing the SDF and SDF + LED groups.

  1-Immediately after caries excavation (baseline - D₁) 2-Immediately after SDF or SDF + LED application (D₂) 3-One week after treatment (follow-up - D₃)

Study Arms (2)

SDF Group

ACTIVE COMPARATOR

Following caries excavation in Class II primary molar cavities, 38% silver diamine fluoride (SDF) will be applied using a microbrush for 1 minute. Excess material will be gently removed with an air-water spray. No light activation will be performed.

Device: DIAGNOdent measurement

SDF-LED Group

EXPERIMENTAL

Following caries excavation, 38% SDF will be applied using a microbrush for 1 minute, followed by LED light activation using a blue curing unit (470 nm wavelength, 1000-1200 mW/cm² intensity) for 20 seconds.

Device: DIAGNOdent measurement

Interventions

DIAGNOdent measurement DEVICE

Residual caries activity will be evaluated with the DIAGNOdent laser fluorescence device (KaVo, Germany) at three time points: 1. Immediately after caries excavation (D₁ - baseline), 2. Immediately after SDF application (D₂), 3. One week after application (D₃). At each time point, DIAGNOdent readings will be recorded three times per site and averaged for analysis.

SDF Group; SDF-LED Group

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4 to 9 years who apply to the Department of Pediatric Dentistry, Faculty of Dentistry, Çanakkale Onsekiz Mart University.
• Medically healthy children with no systemic or chronic disease.
• Cooperative children who can tolerate clinical procedures and measurements.
• Presence of at least one Class II carious lesion in a primary molar tooth.
• Teeth that have undergone caries excavation by another clinician and received 38% silver diamine fluoride (SDF) application (with or without LED activation).
• Teeth that have not yet been restored after SDF (± LED) treatment.
• Written informed consent obtained from parents or legal guardians through an approved consent form.

You may not qualify if:

• Children with systemic or chronic diseases.
• History of allergic reactions or known hypersensitivity to silver, ammonia, or fluoride compounds.
• Uncooperative children or those with insufficient mouth opening during measurement procedures.
• Teeth with pulpal exposure, fistula, abscess, or signs of acute infection.
• Teeth that have previously received any restorative or endodontic treatment.
• Participants who miss the follow-up appointment or whose DIAGNOdent measurements could not be completed.

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (1)

Canakkale Onsekiz Mart University

Çanakkale, 17100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: December 10, 2025
• Primary Completion: January 20, 2026
• Study Completion: January 30, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

TU (1)