drugset / Trial / NCT07023939

Atraumatic Versus Silver-Modified Atraumatic Restorative Treatment in Primary Molars

NCT07023939

Phase 4 Completed 34 enrolled Beirut Arab University
RandomizedCrossoverSingle-blindTreatment

Summary

The goal of this clinical trial is to evaluate and compare the short-term effectiveness of two minimally invasive treatments-Atraumatic Restorative Treatment (ART) and Silver-Modified Atraumatic Restorative Treatment (SMART)-in managing dentine caries lesions in the primary molars of children aged 3 to 7 years with Early Childhood Caries (ECC). The main questions it aims to answer are: * Which treatment method (ART or SMART) results in higher clinical success after six months? * How do ART and SMART treatments affect the Oral Health-Related Quality of Life (OHRQoL) of the children? The researcher will compare teeth restored using ART with those treated using SMART (which includes the application of silver diamine fluoride before restoration) to see if one approach leads to better restoration outcomes and to assess how these restorations will impact the quality of life. Participants will: * Receive both types of treatments in different teeth (split-mouth design). * Undergo clinical evaluation of the treated teeth at baseline and six months to assess success based on restoration retention, integrity, and absence of secondary caries. * Have their parents complete a quality-of-life questionnaire (A-ECOHIS) at the start and at the six-month follow-up.

Timeline

Start
2023-05-02
Primary completion
2024-01-16
Completion
2024-12-10

Drugs

EvaluationDrugModalityDoseRoute
Subject silver diammine fluoride Small molecule 38 % Topical

Indications