Management of Molar Incisor Hypomineralization With Silver Diamine Fluoride or SMART

Not Applicable

Completed

• Conditions: Dental Caries; Molar Incisor Hypomineralization
• Interventions: Device: SDF+KI; Device: SDF+KI+GIC(SMART)

• Registration Number: NCT03862014
• Lead Sponsor: Hacettepe University

Brief Summary

The purpose of this study is to evaluate and compare the clinical performance of Silver diamine Fluoride+Potassium Iodide (SDF+KI) and Silver-Modified Atraumatic Restorative Technique (SMART/SDF+KI+GIC) on molars with MIH

Detailed Description

SDF+KI and SMART (SDF+KI+GIC) were placed on two permanent molar teeth with MIH, in a split mouth design. 48 patients were included in the study. The teeth were randomized into two groups according to the dental restorative material.

Group 1: SDF+KI (Riva Star), Group 2: SDF+KI (Riva Star) +GIC (Equia Forte). The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) was used for clinical evaluation of atraumatic resin restorations. The restorations were evaluated at baseline and 1., 6., 12., 18., 24. months. Intra-oral photos were taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification.

Fisher's Exact test, Kaplan-Meier Survival Curves, Log-rank test, Mann Whitney U test, and Friedman test was performed for the statistical analysis.

Study Timeline

• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-05
• Study Start: 2019-07-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Patients and parents of the patients who accept to participate and sign the informed consent
• Patients whose molar teeth are diagnosed as molar incisor hypomineralization by EAPD
• Teeth that are fully erupted
• Patients who have at least two permanent first molars that need fissure sealant
• Teeth that have white-yellow-brown discoloration that indicate high-caries risk

Exclusion Criteria

• Teeth that are previously restored or have caries
• Patients who have orthodontic treatment
• Patients who are not cooperative for the dental procedure
• Teeth that have dental fluorosis or enamel malformation according to the specific syndromes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SDF+KI	SDF+KI	SDF+KI will be applied on molars with MIH
SMART(SDF+KI+GIC)	SDF+KI+GIC(SMART)	SDF+KI+GIC will be applied on molars with MIH

Primary Outcome Measures

Name	Time	Method
Clinical performance of SDF+KI and SMART(SDF+KI+GIC) on molars with MIH	2 years	The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of atraumatic resin restorations.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey