Clinical Trials Directory

Trials / Completed

CompletedNCT03862014

Management of Molar Incisor Hypomineralization With Silver Diamine Fluoride or SMART

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
48 (actual)
Sponsor
Hacettepe University · Academic / Other
Sex
All
Age
6 Years – 13 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

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

Timeline

Start date
2019-07-01
Primary completion
2022-06-01
Completion
2022-06-01
First posted
2019-03-05
Last updated
2024-05-17

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT03862014. Inclusion in this directory is not an endorsement.