Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05540171 |
| Other study ID # |
NHREC/17/03/2018 |
| Secondary ID |
2D43TW010543-06 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 22, 2022 |
| Est. completion date |
September 15, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Aminu Kano Teaching Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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=172) 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.
Description:
The paediatric HIV clinic sites will be randomized into intervention and control groups and
all consecutive consenting eligible participants will be recruited and enrolled into the
study at the sites until the estimated sample size for each study arm (86 participants per
arm) is reached. The number of participants per arm will be allocated in proportions observed
from each site's population. Baseline data collection will commence after all participants
have been screened, recruited, and enrolled. The intervention arm will consist of oral health
education and demonstration of how to perform oral self-care.
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 172 (86 participants/arm).
Ethical Approval: Has been obtained from Aminu Kano Teaching Hospital (AKTH) and Kano State
research ethics committees.
Study instrument/measures:
1. Socio-demographic/clinical information: Age, gender, family size, household income,
caregiver occupation/education, birth order/rank, HIV status of caregiver
(self-reported/extracted from records), child's antiretroviral treatment (ART) regimen,
comorbidities, most recent viral load, helper T cells (CD4+) count.
2. 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.
3. Oral health status:
i. Decayed, Missing, and Filled Teeth (DMFT/dmft) index, scored: D/d, M/m, F/f.
ii. International Caries Detection and Assessment System, (ICDAS) (caries severity)
(0=sound tooth- 6=distinctly cavitated tooth).
iii. Pulp (visible), Ulceration (oral mucosa), Fistula and Abscess due to caries
(PUFA/pufa) index scored: P/p, U/u, F/f, A/a.
iv. 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).
v. Gingival index (GI): 0=normal gingiva, 3=severely inflamed gingiva/spontaneous
bleeding.
vi. Other lesions present (including HIV-associated oral lesions).
Study Procedures/Data collection:
One trained research assistant (RA) per site will be hired, trained, and calibrated
(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.
All participants will be frequency matched.
Intervention: Trained instructor will give 45-minute oral health education and
instructions/training for self-oral care to groups of 4 or 5 children and primary
caregivers along with cards for oral self care record purposes.
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 leaflets reinforcing the oral health education will be
provided. Reminders will be sent out monthly via text messages.
Control arm: will not receive oral health intervention at the time of the study, but as
soon as the period of the study is over, the intervention will be given.
Participants with findings that require treatment will be linked to appropriate services
and they will be financially responsible for such care. All participants will receive
toothbrushes and toothpastes as incentive and funds for transportation cost during study
visits.
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.
