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

NCT05727475 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2023-11-14

No results posted yet for this study

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.

Conditions

  • Molar Incisor Hypomineralization

Interventions

PROCEDURE

Minimal invasive restorative treatment

Composite veneer facing without drilling or removal of enamel

PROCEDURE

Fluoride gel application

Fluoride gel application 1.23%

Sponsors & Collaborators

  • Jordan University of Science and Technology

    collaborator OTHER

  • King Abdullah University Hospital

    lead OTHER

Principal Investigators

  • Ola B. Al-Batayneh · Jordan University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-12
Primary Completion
2023-06-01
Completion
2023-06-01

Countries

  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05727475 on ClinicalTrials.gov