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Completed

NCT Number: NCT03862014

Management of Molar Incisor Hypomineralization With Silver Diamine Fluoride or SMART

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

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Key information

Conditions

Dental Caries Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Enamel Hypomineralization Developmental Defects of Enamel Molar Hypomineralization Molar Incisor Hypomineralization Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Demineralization Tooth Diseases

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SDF+KI

Device

Molar with MIH will be treated with SDF+KI

SDF+KI+GIC(SMART)

Device

Molar with MIH will be treated with SDF+KI+GIC(SMART)

Primary outcomes

  1. Clinical performance of SDF+KI and SMART(SDF+KI+GIC) on molars with MIH

    Time frame: 2 years

    The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of atraumatic resin restorations.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Clinical Evaluation of Permanent Molars With Molar Incisor Hypomineralization Treated With Silver Diamine Fluoride or Silver Modified Atraumatic Restorative Technique

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2019
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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