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
| Type | Name | Description |
|---|---|---|
| DEVICE | SDF+KI | Molar with MIH will be treated with SDF+KI |
| DEVICE | SDF+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.