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.: PACTR201801002890993 Date of Approval: 19/12/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title School oral health promotion
Official scientific title COMPARISON OF SCHOOL-BASED ORAL HEALTH PROMOTION STRATEGIES AMONG ADOLESCENTS IN IBADAN, NIGERIA
Brief summary describing the background and objectives of the trial Oral health promotion programmes are largely dependent on dentist as the delivery resource person. However, the number of dentists in developing countries like Nigeria is few, making coverage on a wider base difficult. This has contributed to the low oral health awareness, poor oral health and high level of unmet dental needs in adolescent and other age groups in the country. A need therefore arises to explore feasibility and effectiveness of oral health promotion activities led by other resource persons such as peers and teachers. This study will compare oral health promotion activities conducted by three resource persons (peer, teacher and the dentist) towards improving oral health among adolescents in Ibadan. The objectives of the study include to establish baseline data on the perception of knowledge of students and teachers on the importance of oral health, to evaluate the relative effectiveness of school based oral health promotion strategies on oral health and quality of life of the students and to assess the students and teachers acceptability of the strategies as well as the fidelity of the school based oral health promotion strategies
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SBOHPP
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/01/2018
Actual trial start date 07/05/2018
Anticipated date of last follow up 13/09/2018
Actual Last follow-up date 10/12/2019
Anticipated target sample size (number of participants) 1608
Actual target sample size (number of participants) 1608
Recruitment status Completed
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 randomisation using ballot papers Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Nil Nil Three school terms Nil 402 Placebo
Experimental Group Teacher-led oral health promotion once every two weeks Three school terms Teacher led oral health promotion 402
Experimental Group Dentist-led oral health promotion strategy once every two weeks Three school terms Dentist-led oral health promotion strategy 402
Experimental Group Peer-led oral health promotion strategy once every two weeks Three school terms Peer-led oral health promotion programme 402
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Only students and teachers who give their consents Students with no special needs. Students that are able to communicate freely. Students whose parents do not consent or who do not assent Teachers and students who will not be available at the time of the study will not be included in the study. 14 Year(s) 18 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 06/04/2018 Oyo State Ethics Review Board
Ethics Committee Address
Street address City Postal code Country
Ministry of Health, Secretariat, Ibadan Ibadan 1111 Nigeria
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 26/04/2018 University of Ibadan and University College Hospital Institutional Ethics Review Board
Ethics Committee Address
Street address City Postal code Country
Queen Elizabeth II Road Ibadan 11111 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improved oral health status Six months post intervention
Primary Outcome Oral health knowledge, attitude and practices six weeks and six months
Secondary Outcome Perceptions of the students and teachers about oral health Baseline
Secondary Outcome Acceptability and fidelity of the school-based oral health strategies six months post-intervention
Secondary Outcome Oral health related quality of life of the students Six months post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Public Secondary Schools in Ibadan LGA Ibadan Ibadan +234 Nigeria
College of Medicine, University of Ibadan University of Ibadan Ibadan +234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
CARTA Kenya, South Africa, Nigeria Ibadan +234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CARTA University of Ibadan Ibadan +234 Nigeria Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Prof Gbemi A Oke University of Ibadan Ibadan +234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Folake Lawal folakemilawal@yahoo.com +2348023658988 University of Ibadan, Ibadan
City Postal code Country Position/Affiliation
Ibadan +234 Nigeria Lecturer
Role Name Email Phone Street address
Public Enquiries Folake Lawal folakemilawal@yahoo.com +2348023658988 University of Ibadan, Ibadan
City Postal code Country Position/Affiliation
Ibadan +234 Nigeria Lecturer
Role Name Email Phone Street address
Scientific Enquiries Folake Lawal folakemilawal@yahoo.com +2348023658988 University of Ibadan, Ibadan
City Postal code Country Position/Affiliation
Ibadan +234 Nigeria Lecturer
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information