Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202408741381767 Date of Registration: 15/08/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title IMPROVE: Improving Oral Health for Vulnerable Populations
Official scientific title Effectiveness of Oral Health Promotion Intervention in Preventing Oral Health Problems Among Children Living in Orphanages in Ibadan, Nigeria – A Cluster Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Oral health constitutes an integral facet of overall well-being, significantly impacting the quality of life and systemic health of individuals. Dental caries and periodontal diseases, which encompass a spectrum of oral conditions, remain substantial public health concerns worldwide, particularly within low and middle-income countries, including Nigeria. Among these, children residing in orphanages represent a segment of the population that faces inequitable oral health challenges. The context in Nigeria presents particular challenges, with over seventeen million orphaned and vulnerable children. Orphans and vulnerable children face social isolation, restricting their access to dental health services and education. Being an orphan is a significant predictor of poor oral health, with a higher burden compared to non-orphans. Poor oral hygiene practices and inadequate dietary habits are the major exacerbating factors for their susceptibility to oral health problems. While there is a dearth of empirical information about the oral health status of children living in orphanages in Nigeria, a study among orphans in Lagos reported a 67% prevalence of periodontal disease among them. The proposed study seeks to bridge the existing gap in knowledge by assessing the effectiveness of oral health lectures aided by posters on oral hygiene knowledge, attitude, practices, status, and gingival health among children living in orphanages in Ibadan, Nigeria. By collaborating with both children and caregivers, this study aims to design culturally sensitive interventions that encourage sustainable oral health practices.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 12/08/2024
Actual trial start date 12/08/2024
Anticipated date of last follow up 28/02/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oral Health Lectures The selected children and their carers will receive one session of the intervention lasting for about 40 minutes One session of the intervention lasting for about 40 minutes The intervention will involve an oral health education lecture delivered by a Community Dentist, aided by posters and the provision of oral cleaning aids including toothpaste, toothbrushes, and dental floss. The selected children (other children will not be denied but the focus will be on those selected to participate in the study) and their carers will receive the lectures aided by the posters. There will be one session of the intervention lasting for about 40 minutes. Subsequently, the posters will be pasted in different areas in the orphanages, particularly the bedrooms and halls/sitting rooms. All the children in the orphanage will be given one toothpaste, toothbrush, and dental floss. 150
Control Group Handwashing hygiene One session 15 minutes Participants in the control group will not receive oral health educational interventions aided by posters. Instead, they will receive an health talk on appropriate hand hygiene practices. They will also each receive one toothpaste, toothbrush, and dental floss. After the completion of the study, a session of oral health educational intervention will be given to them for the sake of beneficence. 150 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children with ages ranging from 10 years to 17 years living in orphanages in Ibadan, Nigeria Children who have a hearing or visual impairment and those who are physically challenged (poor hand and muscle control) will be excluded from the study. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 10 Year(s) 17 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/08/2023 University of Ibadan and University College Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
IAMRAT Building, Queen Elizabeth Road Ibadan 200285 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Gingival index - Health of the gingivae/gums Baseline and six months post-intervention
Secondary Outcome 1. Oral health knowledge 2. Attitude towards oral hygiene practices Baseline, immediate post-intervention, and six months post-intervention
Secondary Outcome 1. Oral hygiene practices 2. Oral hygiene status 3. Susceptibility to use tobacco and other substances 4. Tobacco and substance use status Baseline and six months post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ibadan Queen Elizabeth Road Ibadan 200285 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Omotayo Francis Fagbule Flat C165, Residential Quarters, University College Hospital Ibadan 200285 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Omotayo Francis Fagbule Flat C165, Residential Quarters, University College Hospital Ibadan 200285 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omotayo Fagbule ffagbule@gmail.com +2348037699380 Flat C165, Residential Quarters, University College Hospital
City Postal code Country Position/Affiliation
Ibadan 200285 Nigeria Public Health Dentist
Role Name Email Phone Street address
Public Enquiries Chukwuma Asika asikachukwuma@gmail.com +2348064602058 Family Dentistry Building, Queen Elizabeth Road
City Postal code Country Position/Affiliation
Ibadan 200285 Nigeria Senior Registrar and Specialist Family Dentist
Role Name Email Phone Street address
Scientific Enquiries Folake Lawal folakemilawal@yahoo.com +2348023658988 Periodontology and Community Dentistry, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Professor and Head of Department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the study report, after deidentification (text, tables, figures, and appendices) will be made available. Study Protocol As from 12 months and ending 5 years after the publication of the articles Researchers who have provided a good scientific proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information