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Management of Molar Incisor Hypomineralization With Silver Diamine Flouride

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ClinicalTrials.gov Identifier: NCT03862014
Recruitment Status : Active, not recruiting
First Posted : March 5, 2019
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Zafer Cavit Cehreli, DDS, PhD, Hacettepe University

Brief Summary:
The purpose of this study is to evaluate and compare the clinical performance of Silver diamine Flouride (SDF) and Silver diamine Flouride + Atraumatic resin restoration (SDF+ARR) on molars with MIH

Condition or disease Intervention/treatment Phase
Dental Caries Molar Incisor Hypomineralization Device: SDF only Device: SDF+ARR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Evaluation of Permanent Molars With Molar Incisor Hypomineralization Treated With Silver Diamine Flouride or Silver Diamine Flouride+Atraumatic Restorative Technique
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : April 1, 2022

Arm Intervention/treatment
Experimental: SDF only
SDF will be applied on molars with MIH
Device: SDF only
Molar with MIH will be treated with SDF

Active Comparator: SDF+ARR
SDT+ARR will be applied on molars with MIH
Device: SDF+ARR
Molar with MIH will be treated with SDF+ARR




Primary Outcome Measures :
  1. Clinical performance of SDF and SDF+ARR on molars with MIH [ Time Frame: 2 years ]
    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.



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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 flourosis or enamel malformation according to the specific syndromes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862014


Locations
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Turkey
Hacettepe University
Ankara, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Zafer Cehreli Hacettepe University
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Responsible Party: Zafer Cavit Cehreli, DDS, PhD, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT03862014    
Other Study ID Numbers: MIH-SDF/ARR
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zafer Cavit Cehreli, DDS, PhD, Hacettepe University:
molar incisor hypomineralization
silver diamine flouride
Additional relevant MeSH terms:
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Dental Caries
Dental Enamel Hypoplasia
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities