Management of Molar Incisor Hypomineralization With Silver Diamine Fluoride or SMART

May 15, 2024 updated by: Zafer Cavit Cehreli, DDS, PhD, Hacettepe University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SDF+KI
SDF+KI will be applied on molars with MIH
Device: SDF+KI
Molar with MIH will be treated with SDF+KI
Active Comparator: SMART(SDF+KI+GIC)
SDF+KI+GIC will be applied on molars with MIH
Device: SDF+KI+GIC(SMART)
Molar with MIH will be treated with SDF+KI+GIC(SMART)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Zafer Cehreli, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

March 1, 2019

First Submitted That Met QC Criteria

March 1, 2019

First Posted (Actual)

March 5, 2019

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIH-SDF/SMART

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD is available from the corresponding author on reasonable request

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Access Criteria

IPD is available from the corresponding author on reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Caries

Clinical Trials on SDF+KI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe