Management of Molar Incisor Hypomineralization With Silver Diamine Flouride
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|ClinicalTrials.gov Identifier: NCT03862014|
Recruitment Status : Active, not recruiting
First Posted : March 5, 2019
Last Update Posted : March 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries Molar Incisor Hypomineralization||Device: SDF only Device: SDF+ARR||Not Applicable|
SDF and SDF+ARR will be placed on two permanent molar teeth with MIH, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into two groups according to the dental restorative material.
Group 1: SDF only ((Riva Star) 2: SDF (Riva Star) +ARR (Equia Forte). The US Public Health Service criteria (secondary caries, anatomical form, surface roughness, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of atraumatic resin restorations. The restorations will be evaluated at baseline and 1., 6., 12., 18., 24. months. Intra-oral photos will be taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification.
The data will be analysed statistically using Fisher's Exact Test; and the Kaplan-Meier and Wilcoxon method will be used to estimate survival percentages.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of Permanent Molars With Molar Incisor Hypomineralization Treated With Silver Diamine Flouride or Silver Diamine Flouride+Atraumatic Restorative Technique|
|Actual Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||April 1, 2022|
Experimental: SDF only
SDF will be applied on molars with MIH
Device: SDF only
Molar with MIH will be treated with SDF
Active Comparator: SDF+ARR
SDT+ARR will be applied on molars with MIH
Molar with MIH will be treated with SDF+ARR
- Clinical performance of SDF and SDF+ARR on molars with MIH [ Time Frame: 2 years ]The US Public Health Service criteria (secondary caries, anatomical form, surface roughness, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of atraumatic resin restorations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862014
|Ankara, Turkey, 06100|
|Principal Investigator:||Zafer Cehreli||Hacettepe University|