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.: PACTR201608001717691 Date of Approval: 15/07/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Oral Health promotion in schools
Official scientific title Evaluation of two oral health education methods in promoting oral health in schools in Ibadan, Nigeria
Brief summary describing the background and objectives of the trial The non-existence of school based prevention programmes is a source of concern in a country with high prevalence of oral diseases. The school based oral health promotion programmes have been found effective in improving the oral hygiene of the school pupils in some countries where the programme was regularly implemented. However, inadequate knowledge of oral health and poor oral hygiene practices by teachers in elementary schools has been shown to hinder implementation of school oral health education. There are different methods of oral health education but none has been tested against the other towards institution of oral health promoting school in this environment. The aim of the proposed study is to evaluate two oral health education methods in the development of the school based oral health promotion programme in Ibadan. The study will be conducted in schools selected through multistage sampling in a Local Government Area of Ibadan. These schools will be randomly allocated into two study groups and one control group. Baseline assessment of the oral health knowledge, attitude and practices of the three groups will be obtained using interviewer administered questionnaires in addition to which intraoral examination will be performed. The control group will receive no intervention while study group I will receive lectures on oral health education once a term for three terms, and study group II will be receive initial lecture and then engage in group work on selected topics on oral health, which will involve the pupils supervised by their teachers each term for three school terms. The teachers and randomly selected students in the three schools will be evaluated after the three school terms using interviewer administered questionnaires and by oral examination to determine the impacts of the intervention on their knowledge, attitude and practices in relation to oral health as well as its impact on their oral health status. Data will be analyzed using SPSS
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 26/01/2015
Actual trial start date 25/05/2015
Anticipated date of last follow up 05/12/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 1050
Actual target sample size (number of participants)
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oral health education lectures once a school term three school terms oral health education lectures 350
Experimental Group Initial oral health education lectures and subdequent group work Once a school term Three school terms Pupils in this group will receive an initial oral health education lectures and subsequently will engage in group work on selected oral health under the supervision of their teachers 350
Control Group No intervention three school terms No intervention was given to the control group 350 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Consenting pupils who are available at the time of the study Pupils in selected schools aged 8-14 years Pupils in whom oral examination can be conducted Those whose parents consented shall be recruited for the study Ill pupils or those with chronic systemic illnesses Those in whom oral examination cannot be done or will be difficult Those not willing to consent to participate in the study Those with mental disability or with physical disability that could affect the outcome of the study Pupils that will not be available at the time of the study Pupils who have other sources of oral health education 8 Year(s) 14 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 03/11/2014 Oyo State Ethics Review Board,Ministry of Health
Ethics Committee Address
Street address City Postal code Country
Department of Planning,Research and Statistics Division, Ministry of Health, Secretariat, Ibadan Ibadan PMB 5027 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improved oral health status After two terms After three terms
Secondary Outcome Oral health knowledge, attitude and practices After two school terms and after three school terms
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Public Primary Schools in Ibadan North East LGA Ibadan North East Local Government Area Ibadan PMB 5027 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
College of Medicine, University of Queen Elizabeth II Road, Total Garden Ibadan +234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor College of Medicine, University of Queen Elizabeth II Road, Total Garden Ibadan PMB 5017 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Prof Gbemi A Oke University of Ibadan, Ibadan Ibadan PMB 5017 Nigeria
Prof Juliana Taiwo Faculty of Dentistry, College of Medicine, University of Ibadan Ibadan PMB 5017 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Folake Lawal folakemilawal@yahoo.com +2348023658988 Faculty of Dentistry, College of Ibadan,University of Ibadan, Ibadan
City Postal code Country Position/Affiliation
Ibadan PMB 5017 Nigeria
Role Name Email Phone Street address
Public Enquiries Folake Lawal folakemilawal@yahoo.com +2348023658988 Faculty of Dentistry, College of Ibadan,University of Ibadan, Ibadan
City Postal code Country Position/Affiliation
Ibadan PMB 5017 Nigeria Lecturer
Role Name Email Phone Street address
Scientific Enquiries Folake Lawal folakemilawal@yahoo.com +2348023658988 Faculty of Dentistry, College of Ibadan,University of Ibadan, Ibadan
City Postal code Country Position/Affiliation
Ibadan PMB 5017 Nigeria Lecturer
REPORTING
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