A randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services - NIC-PIP Northern Ireland Caries Prevention in Practice Trial

Phase 1

• Conditions: Dental Caries; MedDRA version: 14.1 Level: PT Classification code 10012318 Term: Dental caries System Organ Class: 10017947 - Gastrointestinal disorders

• Registration Number: EUCTR2009-010725-39-GB
• Lead Sponsor: The University of Manchester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-14
• Study Completion: 2015-06-22
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1248

Inclusion Criteria

•Children aged 2 and 3 years
•Attending selected GDS practices
•Person with parental responsibility signs a Consent Form

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Children with caries into dentine
•A past history of fillings or extractions due to caries
•Children with fissure sealants on primary molar teeth
•Children with history of severe allergic reactions requiring hospitalisation
•Children already participating in any other IMP study at recruitment

•Siblings Rule. Families usually attend the dentist as a unit; therefore a rule is needed to determine the participation of siblings in the trial. The youngest eligible sibling in a family will be randomised and all other eligible siblings will be excluded from the study and receive their NHS dental care in the usual way.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified