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.: PACTR202310921251454 Date of Approval: 12/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Using traditional folklore through visual arts as a tool for oral hygiene education among Nigerian schoolchildren
Official scientific title Traditional folklore through visual arts: A tool for school-based oral hygiene education among primary school pupils in Ibadan, Oyo State, Nigeria
Brief summary describing the background and objectives of the trial Oral health diseases represent a significant public health challenge in numerous developing countries, Nigeria included. While many of these diseases, such as dental caries and gum diseases, can be readily prevented through proper oral hygiene practices, a substantial portion of the population, particularly children, lacks the necessary knowledge and attitudes to maintain good oral health. Consequently, there is a pressing need for effective and sustainable programs aimed at enhancing their oral hygiene knowledge and attitudes. The call for intensified initiatives and innovative strategies to promote oral health and alleviate the burden of oral diseases remains inadequately answered. This study aims to determine the effectiveness of traditional folklore as a tool for enhancing: (1) oral health hygiene knowledge and (2) oral hygiene attitudes of Nigerian schoolchildren
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 01/12/2023
Actual trial start date
Anticipated date of last follow up 19/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 228
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 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 Traditional folklore presented through visual arts There would be one session of the intervention lasting for about 35 minutes each, and questions and clarifications would be entertained for an estimated period of 10 minutes. Only one session lasting 45 minutes. The folktale involves “Ijapa tiroko’, his wife ‘Yanibo’, and his friends from the animal kingdom. The folktale will incorporate the following messages: knowledge about good oral hygiene practices, good dietary practices, oral care facility utilization, and attitudes concerning good oral hygiene practices, good dietary practices, and oral care facility utilization. The intervention will be administered via a 6-foot by 4-foot visual banner and will contain graphically designed illustrations (comic strips) of the folktale. This will then be presented within the classroom while the pupils are seated comfortably in their seats, and will be facilitated by the instructor (researcher). 114
Control Group Oral health talk One session of oral health talk would last about 35 minutes, and questions and clarifications would be entertained for an estimated 10 minutes. Only one session, which is estimated to last for 45 minutes The participants in the Control Group will receive health talks on adequate oral hygiene and dietary practices, oral care facility utilization, and attitudes concerning good oral hygiene practices, good dietary practices, and oral care facility utilization. They will receive a similar message as those in the Intervention group, with the only difference being the method of delivery. 114 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Primary 4 (Grade 4) pupils who are attending either public or private primary schools located in Ibadan, Oyo State, Nigeria Schools that are not registered with the government will be excluded from the study Pupils who are absent from school during the recruitment exercise Pupils whose parents/legal guardians refuse consent and fail to sign the Parental Consent Form Child: 6 Year-12 Year 8 Year(s) 10 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 20/09/2023 University of Ibadan and University College Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Queen Elizabeth Road Ibadan 200212 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 20/09/2023 University of Ibadan and University College Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Queen Elizabeth Road Ibadan 200212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Oral hygiene knowledge Baseline, Immediate post-intervention, and One-month post-intervention
Secondary Outcome Attitude towards oral hygiene practices Baseline, Immediate post-intervention, and One-month post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital Queen Elizabeth Road Ibadan 200212 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nigerian Division of the International Association of Dental Research Ishaga Rd, Idi-Araba Lagos 102215 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Omotayo Francis Fagbule 7 Circular Road, University College Hospital Ibadan 200212 Nigeria Individual
Secondary Sponsor Dr Olushola Ibiyemi Department of Periodontology and Community Dentistry, University College Hospital Ibadan 200212 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Iyanuoluwa Ajayi iyanuajayi@gmail.com +2348099412354 University College Hospital
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Dentist
Role Name Email Phone Street address
Scientific Enquiries Omotayo Fagbule ffagbule@gmail.com +2348037699380 No. 7 Circular Road, University College Hospital
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Public Health Dentist and Specialist
Role Name Email Phone Street address
Public Enquiries Olushola Ibiyemi shola_ibiyemi@yahoo.com +2348037201253 University College Hospital
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Associate Professor and Public Health Dentist
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 1 year 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