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NCT03862014 Clinical Trial

Management of Molar Incisor Hypomineralization With Silver Diamine Fluoride or SMART

Dental Caries Clinical Trial

Official title:
Clinical Evaluation of Permanent Molars With Molar Incisor Hypomineralization Treated With Silver Diamine Fluoride or Silver Modified Atraumatic Restorative Technique

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03862014
Other study ID # MIH-SDF/SMART
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2019
Est. completion date June 1, 2022

Study information
Verified date May 2024
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date June 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 13 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)
Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 2 years
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