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NCT05727475
Change in OHRQOL Following Minimally Invasive Treatment of Anterior Teeth in Children With MIH
Conditions: Molar Incisor Hypomineralization
Sex: All
Ages: 6 Years – 16 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 156
Sponsor: King Abdullah University Hospital
Location: Jordan
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.
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; andChildren with poor behavior.
Source: ClinicalTrials.gov (NCT05727475). StuddyBuddy aggregates publicly available trial information.