Management of Molar Incisor Hypomineralization With Silver Diamine Fluoride
Primary Purpose
Dental Caries, Molar Incisor Hypomineralization
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
SDF only
SDF+ARR
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring molar incisor hypomineralization, silver diamine fluoride
Eligibility Criteria
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
Sites / Locations
- Hacettepe University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SDF only
SDF+ARR
Arm Description
SDF will be applied on molars with MIH
SDF+ARR will be applied on molars with MIH
Outcomes
Primary Outcome Measures
Clinical performance of SDF and SDF+ARR on molars with MIH
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03862014
Brief Title
Management of Molar Incisor Hypomineralization With Silver Diamine Fluoride
Official Title
Clinical Evaluation of Permanent Molars With Molar Incisor Hypomineralization Treated With Silver Diamine Fluoride or Silver Diamine Fluoride+Atraumatic Restorative Technique
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate and compare the clinical performance of Silver diamine Fluoride (SDF) and Silver diamine fluoride + Atraumatic resin restoration (SDF+ARR) on molars with MIH
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Molar Incisor Hypomineralization
Keywords
molar incisor hypomineralization, silver diamine fluoride
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SDF only
Arm Type
Experimental
Arm Description
SDF will be applied on molars with MIH
Arm Title
SDF+ARR
Arm Type
Active Comparator
Arm Description
SDF+ARR will be applied on molars with MIH
Intervention Type
Device
Intervention Name(s)
SDF only
Intervention Description
Molar with MIH will be treated with SDF
Intervention Type
Device
Intervention Name(s)
SDF+ARR
Intervention Description
Molar with MIH will be treated with SDF+ARR
Primary Outcome Measure Information:
Title
Clinical performance of SDF and SDF+ARR on molars with MIH
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zafer Cehreli
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34743243
Citation
Ballikaya E, Unverdi GE, Cehreli ZC. Management of initial carious lesions of hypomineralized molars (MIH) with silver diamine fluoride or silver-modified atraumatic restorative treatment (SMART): 1-year results of a prospective, randomized clinical trial. Clin Oral Investig. 2022 Feb;26(2):2197-2205. doi: 10.1007/s00784-021-04236-5. Epub 2021 Nov 6.
Results Reference
derived
Learn more about this trial
Management of Molar Incisor Hypomineralization With Silver Diamine Fluoride
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