Oral health related quality of life and comparison between preventive regimens among Iraqi preadolescents
Phase 3
- Conditions
- Oral health condition, Dental caries.Dental caries
- Registration Number
- IRCT20220627055297N1
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 372
Inclusion Criteria
Schoolchildren aged 8-10 years old
Cooperative children
Children with consent parent
Exclusion Criteria
Children with systemic diseases (blood disease, CVD, diabetes mellitus, asthmatic children)
Uncooperative children
Disabled children
Hereditary developmental defect of teeth such as amelogensis imperfecta and dentinogensis imperfecta.
Known allergy /sensitivity to any of dental material that will be used
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Caries progression. Timepoint: Before intervention, 3, and 6 months after intervention. Method of measurement: International caries Detection and Assessment System (ICDAS) according to Braga et al. (2009) will be used in clinical trial phase . D 0 - Sound D1 - First visual change in enamel (white spot opacity first visible change only after air drying: white, brown). D2 - Distinct visual change in enamel (white spot opacity distinct visible change without air- drying: white, brown). D3 -Localized enamel breakdown due to caries with no visible dentin (localized enamel breakdown surface integrity loss) D4-Non-cavitated surface with underlying dark shadow from dentin (underlying dark shadow +/- surface integrity loss) D5 - Distinct cavity with visible dentin. D6 -Extensive distinct cavity with visible dentin.
- Secondary Outcome Measures
Name Time Method Caries increment, and Cost – effectiveness of interventions. Timepoint: Before intervention, 3 and 6 months after intervention. Method of measurement: Decay surfaces (DS, dt ) according to WHO (2013). Criteria and codes of dental caries: 0 (A). Sound tooth 1 (B). Decayed tooth 2 (C). Filled tooth with decay .Dental caries indices: tooth (DT, dt) and surface levels (DS, ds) carious lesions were registered for all surfaces of each tooth included. The Decayed component (D) included all teeth with codes 1 or 2. Costs of preventive regimen will be examined from the perspective of a service provider:1. Direct medical cost ( materials and equipment, capital cost and time spent by service provider)2. Indirect cost (overhead cost).