ACORN: Improving oraI health in cleft lip and/or palate
Not Applicable
Completed
- Conditions
- Specialty: Children, Primary sub-specialty: Cleft and craniofacial anomaliesUKCRC code/ Disease: Oral & Gastro/ Diseases of oral cavity, salivary glands and jawsOral HealthCleft lip and/or palate (CL/P)
- Registration Number
- ISRCTN45791053
- Brief Summary
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28725453 2020 results in https://pubmed.ncbi.nlm.nih.gov/31154601/ (added 08/02/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1. Aged 5-9 years
2. Children with a cleft lip and/or palate (CL/P)
3. One or more parent/carer able to speak and read English
Exclusion Criteria
1. Participation in a Stage 1 interview
2. Children allergic to food dyes
3. Participants unable to converse in English
4. Families undergoing significant psychosocial difficulties (e.g. child protection, recent bereavement of a close family
member), as identified by their cleft team
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acceptability of measures to parents and children is measured by parent and child self-report questionnaires at baseline and 6 month follow up visit and the exit interview with parents at the 6 month follow up visit.
- Secondary Outcome Measures
Name Time Method <br> 1. Child’s dental plaque is measured using the plaque scores on The Modified Gingival Index (MGI) and Plaque Control Record (PCR) at baseline and 6 months<br> 2. Oral hygiene management is measured by a parents’ questionnaire on oral health, a self-report based on Children’s Dental Health Survey and children’s self-report using Day in the Life Questionnaire at baseline and 6 months<br>