An Educational Intervention Program to Improve the Oral Health of HIV-Positive Children in Kano, Nigeria.
The aim of this 2- arm randomized-control study is to determine the effect of an oral hygiene self care intervention on the oral health status and oral health-related quality of life (OHRQoL) of HIV-positive children (age: 8-16 years, n=170) presenting to five pediatric HIV clinics in Kano, Nigeria.
The intervention will comprise oral health education and instructions on oral self-care.
Data on oral health status and OHRQoL will be obtained at baseline and at 1, 3 and 6 months.
Study findings will help inform policies to improve the oral health and OHRQoL of HIV-positive Nigerian children and guide the integration of oral health care services into HIV programs.
|Condition or Disease||Intervention/Treatment||Phase|
Eligible children will be randomized to intervention (oral health education and demonstration of how to perform oral self-care) arm and control (no intervention) arms.
Hypothesis: There will be a mean difference of 0.5 in children's oral hygiene scores between intervention and control arms at 6 months post-intervention.
Based on reported oral hygiene score standard deviation=0.96, desired power=0.90, Type I error rate=0.05, we need 77 participants/arm to detect a clinically meaningful mean difference of 0.5 in oral hygiene score between intervention and control arms at 6 months post-intervention.
To account for possible loss to follow-up over 6 months, the participants' total sample size was increased to 170 (85 participants/arm).
Ethical Approval: Has been obtained from Aminu Kano Teaching Hospital (AKTH) and Kano State research ethics committees.
Socio-demographic/clinical information: Age, gender, family size, household income, caregiver occupation/education, birth history, caregiver self-reported HIV-status (if known), child's antiretroviral treatment (ART) regimen, comorbidities, recent viral load, helper T cells (CD4+) count.
OHRQoL: The child perception questionnaire (CPQ) captures global ratings of child's oral health; four domains: oral symptoms, functional limitations, emotional and social well-being; Likert scale ('never'=0 to everyday/ almost every day'=4). The questionnaire will be translated into Hausa.
Oral health status:
- Decayed, Missing, and Filled Teeth (DMFT/dmft) index, scored: D/d, M/m, F/f.
International Caries Detection and Assessment System, (ICDAS) (caries severity) (0=sound tooth- 6=distinctly cavitated tooth).
Pulp (visible), Ulceration (oral mucosa), Fistula and Abscess due to caries (PUFA/pufa) index scored: P/p, U/u, F/f, A/a.
Oral Hygiene Index-Simplified (OHI-S): comprising Debris index (DI) and Calculus index (CI), each scored 0-3. OHI-S scored: good (0.0-1.2) to poor oral hygiene (3.1-6.0).
Gingival index (GI): 0=normal gingiva, 3=severely inflamed gingiva/spontaneous bleeding.
HIV-associated oral lesions.
Study Procedures/Data collection:
One trained research assistant (RA) per site will be hired (minimum kappa score: 0.8). Consented primary caregivers of eligible children will be contacted by RAs.
Baseline data will be extracted from participants' clinic charts. OHRQoL will be assessed for each participant. Baseline oral health status will be assessed and scored per established guidelines following intra-oral clinical examination.
Participants will be randomly assigned 1:1 to intervention and control arms by a computerized algorithm.
Intervention: Trained instructor will give 45-minute oral health education and instructions/training for self-oral care to each child and primary caregiver.
The intervention will include oral hygiene instructions and motivation for oral self-care (dietary counseling; post-meal rinsing; flossing; brushing frequency, time, and method; tongue cleaning; toothbrush type/care; toothpaste quantity/type; dental visits). Audiovisual aids and flyers reinforcing the oral health education will be provided.
Control arm: will not receive oral health intervention.
Participants with findings that require treatment will be linked to appropriate services; they will be financially responsible for such care. All participants will receive toothbrushes and toothpastes as incentive.
After baseline measurement and intervention to the intervention group, data collection for both groups will be done at 1 month, 3 months and 6, months.
Arms and Interventions
|Experimental: Education intervention (Oral health education and instructions/training for self-oral care)
The intervention arm will be given a 45 minute oral health education which will include oral hygiene instructions and motivation/training for oral self-care (dietary counselling; snacking during and not mealtimes; post-meal rinsing; flossing; brushing frequency, time, and method; tongue cleaning; toothbrush type/care; toothpaste quantity/type; dental visits). Audio-visual aids and leaflets reinforcing the oral health education will also be provided.
Other: Oral health education and instructions/training for self-oral care
|No Intervention: No intervention (Control)
The control arm/group will receive no intervention.
Primary Outcome Measures
- Oral Health Status [6 months]
Oral Hygiene Index-Simplified (OHI-S) score
- Gingival Health Status [6 months]
Modified Gingival Index (MGI) score
- Oral Health Related Quality of Life (OHRQoL) [6 months]
Child Perception Questionnaire for varying ages 8 to 10 and 11 to 14 and upward (CPQ8-10, CPQ11-14)
Secondary Outcome Measures
- Dental Caries Status [One month]
Decayed, Missing, and Filled (DMFT/dmft) index
- Dental Caries Sequelae [6 months]
Pulp which is visible, Ulcerated oral mucosa, Fistula due to caries, Abscess due to caries (PUFA/pufa) index
- Dental Caries Status [6 months]
International Caries Detection and Assessment System (ICDAS)
- HIV-associated oral lesions [One month]
Oral lesions that are associated with HIV
- Other dental problems [One month]
Malocclusion, Molar-Incisor Hypomineralization (MIH), Trauma
HIV-infected children aged 8-16 years (who can self-implement the oral health intervention with minimal caregiver supervision) attending selected clinics. HIV status will be based on clinic records.
Primary caregiver consent; assent from child.
On ART for ≥3 months.
Exclusion Criteria: Children who
Have special health care needs.
Do not meet inclusion criteria.
Decline assent or lack caregiver consent.
Contacts and Locations
LocationsNo locations specified.
Sponsors and Collaborators
- Aminu Kano Teaching Hospital
- NIH Office of AIDS Research (OAR)
- Fogarty International Center of the National Institute of Health
- Principal Investigator: Yewande I ADEYEMO, BDS, Bayero University, Kano/ Aminu Kano Teaching Hospital
Study Documents (Full-Text)None provided.