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Management of Molar Incisor Hypomineralization With Silver Diamine Fluoride or SMART

H

Hacettepe University

Status

Completed

Conditions

Dental Caries
Molar Incisor Hypomineralization

Treatments

Device: SDF+KI+GIC(SMART)
Device: SDF+KI

Study type

Interventional

Funder types

Other

Identifiers

NCT03862014
MIH-SDF/SMART

Details and patient eligibility

About

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

Full 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.

Enrollment

48 patients

Sex

All

Ages

6 to 13 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

48 participants in 2 patient groups

SDF+KI
Experimental group
Description:
SDF+KI will be applied on molars with MIH
Treatment:
Device: SDF+KI
SMART(SDF+KI+GIC)
Active Comparator group
Description:
SDF+KI+GIC will be applied on molars with MIH
Treatment:
Device: SDF+KI+GIC(SMART)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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