Change in OHRQOL Following Minimally Invasive Treatment of Anterior Teeth in Children With MIH
Condition: Molar Incisor Hypomineralization
MeSH terms: Molar Hypomineralization; Dental Enamel Hypoplasia
Study type: Interventional

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.
    

Intervention name(s): Minimal invasive restorative treatment; Fluoride gel application
Intervention type(s): Procedure; Procedure
Intervention description(s): Composite veneer facing without drilling or removal of enamel; Fluoride gel application 1.23%
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Minimally invasive; Esthetic treatment; Oral health related quality of life; C-OHIP-SF19; Composite veneer