Change in OHRQOL Following Minimally Invasive Treatment of Anterior Teeth in Children With MIH

November 13, 2023 updated by: King Abdullah University Hospital

Change in Oral Health-Related Quality of Life Following Minimally Invasive Aesthetic Treatment of Anterior Teeth in Children With Molar Incisor Hypomineralization: A Prospective Clinical Study.

MIH is a prevalent developmental defect which has a negative impact on children's OHRQoL, especially when incisor opacities are present. The aim of this study is to evaluate the change in OHRQoL following minimally invasive aesthetic treatment of anterior permanent teeth opacities in children with MIH using the Arabic C-OHIP-SF19 as a data collection tool.

This RCT will be conducted on children with MIH (n=156), aged 6-16 years, at the Post Graduate (PG) clinics, Jordan University of Science and Technology (Irbid). Patients will be randomly assigned in to two groups: Study group (n=78), with anterior teeth composite facing done to mask the opacity, and control group (n=78) where fluoride gel application was done. Children will be assessed by filling the COHIP-SF19 questionnaire before and one-month after the treatment to evaluate OHRQoL changes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Molar Incisor Hypomineralization (MIH) is defined as a hypomineralized lesion of the enamel as a result of different causes, mainly affecting permanent first molars and frequently associated to similar lesions (that appear as opacities) on upper and/or lower permanent incisors, causing deterioration and destruction of affected teeth because the enamel is fragile, and depending on the severity, may cause teeth to be lost.

Aim: The aim of this clinical study is to evaluate the change in oral health-related quality of life following minimally invasive aesthetic treatment of anterior permanent teeth in children with molar incisor hypomineralization using the Arabic C-OHIP-SF19 as a data collection tool.

Methods: This will be a prospective clinical study which will be performed on a group of school-children with MIH at the Post Graduate (PG) clinics, Jordan University of Science and Technology (JUST), ages 6-16 years. A total of 156 children with MIH and anterior permanent teeth opacities, requesting cosmetic improvement of one or more anterior permanent teeth will be offered a composite facing. They will be asked to fill in the Child Oral Health Impact Profile-Short Form (C-OHIP-SF19) questionnaire pre and 1 month post treatment. The patients will be divided into 2 groups (78 participants per group): Group 1: Restorative group (study group); in this group, a composite facing will be placed on the anterior incisors to mask the opacity. Minimal invasive treatment will be done without drilling or removal of enamel, unless there is caries, which will be removed in this case, and Group 2: Fluoride gel group (control group); in this group, fluoride gel application will be done for all teeth using 1.23% APF gel delivered through a foam tray. In this group, if the child is not happy with the appearance after fluoride gel application, a composite facing will be offered.

Expected results: We expect that MIH patients who undergo the minimally invasive composite facing for the anterior teeth in order to reduce the visibility of enamel opacities to have a higher score on the C-OHIP-SF19 questionnaire because the esthetic treatment can have a positive impact on the children's wellbeing.

Study Type

Interventional

Enrollment (Actual)

156

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:

  • Children with MIH and who have a visible enamel opacity involving at least one anterior permanent tooth;
  • Children who request improvement in their anterior permanent teeth aesthetics.

Exclusion criteria:

  • Children who have an acute dental symptom and require urgent treatment;
  • Children who need to undergo active treatment for their hypomineralized molars during the proposed study period (e.g., extractions) or orthodontic treatment;
  • Children with any dental or facial anomaly other than MIH;
  • Children with compromised incisor aesthetics due to a traumatic dental injury (crown fracture), tooth surface loss, or caries;
  • Children with MIH and who do not have a visible enamel opacity involving at least one anterior permanent tooth; and
  • Children with poor behavior.

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: Study group
In this group, a composite facing will be placed on the anterior incisors to mask the opacity. Minimal invasive treatment will be done without drilling or removal of enamel. They will be asked to fill in the Child Oral Health Impact Profile-Short Form (C-OHIP-SF19) questionnaire pre and 1 month post treatment.
Procedure: Minimal invasive restorative treatment
Composite veneer facing without drilling or removal of enamel
Active Comparator: Control group

In this group, fluoride gel application will be done for all teeth using 1.23% APF gel delivered through a foam tray. They will be asked to fill in the Child Oral Health Impact Profile-Short Form (C-OHIP-SF19) questionnaire pre and 1 month post treatment.

After filling the C-OHIP-SF19 questionnaire 1 month post treatment, if the child is not happy with the appearance after fluoride gel application, a composite facing will be offered.
Procedure: Fluoride gel application
Fluoride gel application 1.23%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OHRQoL changes
Time Frame: After 1 year
Changes OHRQoL before and after the intervention and the difference between both groups (group 1 and 2).
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 12, 2021

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

February 5, 2023

First Submitted That Met QC Criteria

February 5, 2023

First Posted (Actual)

February 14, 2023

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 556-2021

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.

Clinical Trials on Molar Incisor Hypomineralization

Clinical Trials on Minimal invasive restorative treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe