Management of Molar Incisor Hypomineralization With Silver Diamine Fluoride or SMART

N/ACompletedNCT03862014

Hacettepe University48 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Dental Caries Molar Incisor Hypomineralization

Interventions

SDF+KIDEVICE

Molar with MIH will be treated with SDF+KI

SDF+KI+GIC(SMART)DEVICE

Molar with MIH will be treated with SDF+KI+GIC(SMART)

Eligibility

Sex: ALLMin age: 6 YearsMax age: 13 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

Clinical performance of SDF+KI and SMART(SDF+KI+GIC) on molars with MIH

The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of atraumatic resin restorations.

Time frame: 2 years

Data from ClinicalTrials.gov

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