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

Oral health intervention for improving overall health status of children living with HIV in Cambodia: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15177479

Enrollment

780

Registered

2018-01-17

Start date

2018-02-01

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

Oral health in children with HIV infection Oral Health

Interventions

The intervention group and two control groups will be allocated in a 1:1:1 ratio. By the nature of the study, participants and care providers will not be masked. Randomization scheme generated via a c

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Mentally or physically too sick to participate in the study

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Measure

Time frame

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

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Countries

Cambodia

Contacts

Public ContactKimiyo Kikuchi

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026