Clinical trial NCT03862014: Management of Molar Incisor Hypomineralization With Silver Diamine Fluoride or SMART
Official title: Clinical Evaluation of Permanent Molars With Molar Incisor Hypomineralization Treated With Silver Diamine Fluoride or Silver Modified Atraumatic Restorative Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Molar Incisor Hypomineralization
Keywords: molar incisor hypomineralization
silver diamine fluoride
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two materials on two molars in one patient
Primary purpose: PREVENTION

Brief 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.

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

Primary outcomes:
measure: Clinical performance of SDF+KI and SMART(SDF+KI+GIC) on molars with MIH
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Zafer Cehreli
role: PRINCIPAL_INVESTIGATOR
References:
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.