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Oral health related quality of life and comparison between preventive regimens among Iraqi preadolescents

Oral health related quality of life and comparison between preventive regimens among Iraqi preadolescents

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220627055297N1
Enrollment
372
Registered
2022-07-23
Start date
2022-10-01
Completion date
Unknown
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral health condition, Dental caries. Dental caries

Interventions

Basic intervention group (control group) (standard self-care and oral hygiene practices such as brushing two times a day using fluoridated dentifrices, using dental floss, eating appropriate diet an

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 10 Years

Inclusion criteria

Inclusion criteria: Schoolchildren aged 8-10 years old Cooperative children Children with consent parent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Iraq

Contacts

Public ContactHanan Alautry

Shahid Beheshti University of Medical Sciences

hananfadhil@uowasit.edu.iq+98 21 2242 1813

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026