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

Primary Purpose

Molar Incisor Hypomineralization

Status
Active
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Minimal invasive restorative treatment
Fluoride gel application
Sponsored by
King Abdullah University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molar Incisor Hypomineralization focused on measuring Minimally invasive, Esthetic treatment, Oral health related quality of life, C-OHIP-SF19, Composite veneer

Eligibility Criteria

6 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Jordan University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Study group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

OHRQoL changes
Changes OHRQoL before and after the intervention and the difference between both groups (group 1 and 2).

Secondary Outcome Measures

Full Information

First Posted
February 5, 2023
Last Updated
February 17, 2023
Sponsor
King Abdullah University Hospital
Collaborators
Jordan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05727475
Brief Title
Change in OHRQOL Following Minimally Invasive Treatment of Anterior Teeth in Children With MIH
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 12, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Abdullah University Hospital
Collaborators
Jordan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molar Incisor Hypomineralization
Keywords
Minimally invasive, Esthetic treatment, Oral health related quality of life, C-OHIP-SF19, Composite veneer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Minimal invasive restorative treatment
Intervention Description
Composite veneer facing without drilling or removal of enamel
Intervention Type
Procedure
Intervention Name(s)
Fluoride gel application
Intervention Description
Fluoride gel application 1.23%
Primary Outcome Measure Information:
Title
OHRQoL changes
Description
Changes OHRQoL before and after the intervention and the difference between both groups (group 1 and 2).
Time Frame
After 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ola B. Al-Batayneh
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jordan University of Science and Technology
City
Irbid
ZIP/Postal Code
22110
Country
Jordan

12. IPD Sharing Statement

Citations:
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Citation
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PubMed Identifier
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Citation
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Change in OHRQOL Following Minimally Invasive Treatment of Anterior Teeth in Children With MIH

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