Minimally Invasive Treatment for Permanent Molars Affected With Molar-incisor Hypomineralization Defects

May 14, 2025 updated by: King Abdullah University Hospital

Outcome of Minimally Invasive Treatment for Permanent Molars Affected With Molar-incisor Hypomineralization Defects: a Randomized Clinical Trial

In this prospective randomized clinical trial, the is aim to compare the clinical and radiographic success of 3 minimally invasive treatment protocols on permanent first molars affected with MIH over 24 months. A total of 73children/120molar teeth (N=40 molars per group) between the ages of 6-16 years with MIH will be recruited at the post-graduate clinics at Jordan University of Science and Technology (JUST).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: The term molar-incisor hypomineralization (MIH) is defined as 'hypomineralization of systemic origin, presenting as demarcated, qualitative defects of enamel of one to four first permanent molars (FPMs) frequently associated with affected incisors. There are no clinical studies on use of minimally invasive techniques as restorative treatments for molars affected by MIH.

Aim: The aim of this clinical trial is to compare the clinical and radiographic success of 3 minimally invasive treatment protocols on permanent first molars affected with MIH over 24 months.

Methods: A total of 73 children/120 molar teeth (N=40 molars per group) between the ages of 6-16 years with MIH will be recruited for this prospective randomized clinical trial in the post-graduate clinics at JUST. Clinical and radiographic examination will be done. Participants will be randomly allocated to one of the three treatment modalities: For groups 1 and 2, silver diamine fluoride (SDF) will be clinically applied using cotton roll isolation on the first visit for three minutes after cleaning the tooth with gauze. After 1 week, the carious lesion will be examined for signs of caries arrest using two criteria: the color turning darker black and increased hardness of the lesion rather than soft texture (assessed using an excavator), if the criteria are met, the tooth will be restored with high viscosity glass ionomer (HVGIC) and stainless steel crown (SSC) for group 1, or only with a SCC for group 2. If not met, the carious lesion will be assumed to be still active, and a reapplication of SDF will be done before restoring the tooth with HVGIC and SCC. In group 3, the tooth will be restored in a similar fashion to atraumatic restorative treatment (ART technique) and restored with HVGIC and a SCC. Follow up will be done for all groups at 3 months, 6 months, 12 months, and 24 months to record specified clinical and radiographic criteria as outcome measures of success.

Study Type

Interventional

Enrollment (Actual)

73

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

  • Jordan
      • Irbid, Jordan, 22110
        • Jordan University of Science and Technology

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 16 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Permanent molars with MIH with the following MIH indices (2a, 2b, 3, 4a, 4b) affected by caries (ICDAS 3 or 4) or post eruptive breakdown.
  • Restorable teeth
  • Permanent molars with MIH with NO clinical/radiographic signs and symptoms of irreversible pulpitis or pulpal necrosis.
  • Clear band of dentine radiographically between the carious lesion and the pulp.

Exclusion Criteria:

  • Medically compromised patients.
  • Permanent molars with MIH with the following indices (1, 2c, 4c, 0, 1).
  • Permanent molars with MIH with severe post eruptive breakdown therefore, unrestorable.
  • Permanent molars with MIH with clinical/radiographic signs and symptoms of irreversible pulpitis or pulpal necrosis.
  • No clear band of dentine radiographically between the carious lesion and the pulp.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: SDF, HVGIC & SSC
Silver diamine fluoride (SDF) will be clinically applied in the first visit. After 1 week of caries arrest, the tooth will be restored with a high viscosity glass ionomer (HVGIC) and stainless steel crown (SSC).
Procedure: SDF
Silver diamine fluoride
Procedure: HVGIC restoration
High viscosity glass ionomer restoration
Procedure: SSC
Stainless steel crown
Active Comparator: Group 3: HVGIC & SSC
The tooth will be restored in a similar fashion to atraumatic restorative treatment (ART technique) and restored with a high viscosity glass ionomer (HVGIC) and stainless steel crown (SSC).
Procedure: HVGIC restoration
High viscosity glass ionomer restoration
Procedure: SSC
Stainless steel crown
Active Comparator: Group 2: SDF & SSC
Silver diamine fluoride (SDF) will be clinically applied in the first visit. After 1 week of caries arrest, the tooth will be restored with a SSC only.
Procedure: SDF
Silver diamine fluoride
Procedure: SSC
Stainless steel crown

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful restoration
Time Frame: After 1 year
SSC is clinically intact (not perforated), retentive (not lost), in proper occlusion, with no gingival inflammation
After 1 year
Functional tooth clinically
Time Frame: After 1 year
Tooth should have no symptoms of pain, mobility or tenderness to percussion
After 1 year
Healthy periapical region radiographically
Time Frame: After 1 year
No signs of periapical pathology on radiograph
After 1 year

Collaborators and Investigators

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

Sponsor

King Abdullah University Hospital

Collaborators

Jordan University of Science and Technology

Investigators

  • Principal Investigator: Ola B. Al-Batayneh, Jordan University of Science and Technology

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)

November 29, 2021

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

May 1, 2025

Study Registration Dates

First Submitted

February 5, 2023

First Submitted That Met QC Criteria

February 17, 2023

First Posted (Actual)

February 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 623-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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