Oral health intervention for improving overall health status of children living with HIV in Cambodia

Not Applicable

Completed

• Conditions: Oral health in children with HIV infection; Oral Health

• Registration Number: ISRCTN15177479
• Lead Sponsor: Institute of Decision Science for a Sustainable Society, Kyushu University

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30522512 protocol 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37118817/ (added 02/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-17
• Study Completion: 2022-03-31
• Last Update Posted: 15 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

1. Children living with HIV: 3-15 years old, under antiretroviral therapy for at least three months
2. HIV-negative children: 3-15 years old, HIV negative
3. Caregiver: 18 or above, child's primary caregiver

Exclusion Criteria

Mentally or physically too sick to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 01/03/2021:<br> 1. Oral health status (decayed, missing, filled permanent teeth), assessed by dental check by dentist at baseline, mid-term, and endline survey<br> 2. Viral load, CD4 count, measured by blood examination in the routine care of people living with HIV every 3 months<br><br> Previous primary outcome measure:<br> 1. Oral health status (decayed, missing, filled permanent teeth), assessed by dental check by dentist at baseline, mid-term, and endline survey<br> 2. CD4 count, measured by blood examination in the routine care of people living with HIV every 3 months<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Saliva buffer capacity, measured by examining collected saliva by rapid test kit (CAT21buf) at baseline, mid-term, and endline survey<br> 2. Number of cariogenic bacteria, measured by examining collected saliva by rapid test kit (Cariscreen) every 3 months<br> 3. Debris index score, measured by staining plaque with staining liquid for teeth every 3 months<br> 4. Saliva secretion capacity: measured by examining collected saliva by rapid test kit (CAT21buf) at baseline, mid-term, and endline survey<br> 5. Nutrition status, measured by measuring height and weight at baseline, mid-term, and endline survey<br> 6. Quality of life, measured using Pediatric Quality of Life Inventory (version 4.0) every 3 months<br>