Trial no.:	PACTR202208856729489	Date of Approval:	15/08/2022
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Effectiveness of video trained peers and teachers at improving oral health of in-school adolescents in Ibadan, Nigeria

Official scientific title

Feasibility of video supplemented training of peers and teachers at improving oral health of in-school adolescents in Ibadan, Nigeria

Brief summary describing the background and objectives of the trial

Oral health is not accorded much importance in many African countries, mainly because of ignorance arising from poor knowledge, attitude and practices on oral health (1-5). This results in high prevalence of the common and easily preventable oral diseases in these countries (6-10) . Invariably, promotion of oral health during adolescence especially in school becomes very important. In countries where the programme has been successfully implemented, significant lowering in the prevalence of the common oral diseases among children and adolescents have been reported (11-15). Presently, in many developing countries, oral health promotion programs remain the responsibility of the dentist. However, this ought not to be, particularly in the face of short supply of dentist in Nigeria (16). Recent evidence showed that peers and teachers trained by dentists can effectively anchor oral health promotion programs (17). However, its sustainability is threatened by further shortage of dentists in the country needed to train peers and teachers due to brain drain. It therefore becomes important to assess feasibility of training alternatives such as use of pre-recorded videos. This study aims to determine the effectiveness of oral health promotion activities conducted by teachers and peers trained using pre-recorded videos at improving oral health of in-school adolescents in Ibadan, Nigeria. . A cluster randomized controlled trial involving 1350 Senior Secondary School I students in 27 randomly selected schools in three Local Government Areas will be employed. The study will be conducted over 12 months. The students’ oral health knowledge, attitude and practices and oral health status will be assessed using structured self-administered questionnaires and oral examination at baseline and six months after intervention (oral health promotion activities) is completed. After initial assessment, the schools will be randomized into three intervention groups and a control group.

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

26/09/2022

Actual trial start date

17/10/2022

Anticipated date of last follow up

24/04/2023

Actual Last follow-up date

Anticipated target sample size (number of participants)

1350

Actual target sample size (number of participants)

Recruitment status

Closed to recruitment,follow-up continuing

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 by using procedures such as coin-tossing or dice-rolling	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 promotion		six months	This will be in form of a 30mins oral health education and promotion activities conducted by video trained resource persons: Teacher (Group I) .After collection of pre-intervention information from the students, the LGAs will be randomized into three groups by balloting into: teacher-led group, peer-led group and a control group (will receive conventional program). In schools in which oral health promotion intervention will be introduced there will be selection and training of the resource persons for a week and each person will be trained at different times as convenient for him/her and the school authorities as the case in peer led and teacher led strategies. The video training shall be based on a manual for oral health of school students, which has been adapted for this environment and shall consist of basic knowledge of oral health, importance of prevention of oral diseases, oral hygiene habits, diet and smoking. It will also involve identification of poor oral hygiene status by obvious plaque and calculus identification and identification of tooth decay. The skills on good tooth brushing habits will also be taught. The video will record the process of training conducted by a dentist on this skills and information and then sent to the resource persons in the schools for viewing. Questions or difficulties will be communicated back to the principal investigator via WhatsApp, phone or video calls. After training of the different persons to deliver the oral health promotion activities, assessments will be conducted for each participant on the various aspects and a minimum percentage score of 90% will qualify the individual for inclusion as an educator/instructor. The trained teachers would carry out oral health education and promotion activities among selected students in the schools for six months after which post-intervention evaluation shall be conducted	450
Experimental Group	Oral health promotion actvities		Six months	This will be in form of a 30mins oral health education and promotion activities conducted by video trained resource persons: Peer (Group II). After collection of pre-intervention information from the students, the LGAs will be randomized into three groups by balloting into: teacher-led group, peer-led group and a control group (will receive conventional program). In schools in which oral health promotion intervention will be introduced there will be selection and training of the resource persons for a week and each person will be trained at different times as convenient for him/her and the school authorities as the case in peer led and teacher led strategies. The video training shall be based on a manual for oral health of school students, which has been adapted for this environment and shall consist of basic knowledge of oral health, importance of prevention of oral diseases, oral hygiene habits, diet and smoking. It will also involve identification of poor oral hygiene status by obvious plaque and calculus identification and identification of tooth decay. The skills on good tooth brushing habits will also be taught. The video will record the process of training conducted by a dentist on this skills and information and then sent to the resource persons in the schools for viewing. Questions or difficulties will be communicated back to the principal investigator via WhatsApp, phone or video calls. After training of the different persons to deliver the oral health promotion activities, assessments will be conducted for each participant on the various aspects and a minimum percentage score of 90% will qualify the individual for inclusion as an educator/instructor. The trained peers would carry out oral health education and promotion activities among selected students in the schools for six months after which post-intervention evaluation would be conducted	450
Control Group	Conventional		Six months	Conventional oral health program	450	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Students with no special needs Students who are able to communicate freely.	Students whose parents do not consent Students who do not assent to the study Students who would not be available at the time of the study	Adolescent: 13 Year-18 Year	13 Year(s)	19 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

17/10/2022

University of Ibadan University College Hospital Ibadan

Ethics Committee Address
Street address	City	Postal code	Country
Queen Elizabeth II Road, UCH	Ibadan	2000212	Nigeria

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	• Self-reported dental outcome by adolescents as defined by presence or absence of impairment on oral function, orofacial pain, orofacial appearance and psychosocial impact • Oral hygiene status of the adolescents as defined by the number of sextants with dental plaque, calculus • Gingiva that will bleed to probing	Baseline, six months post-intervention
Secondary Outcome	Oral health knowledge, attitude and practices of the adolescents	Baseline and six months post-intervention

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Schools in three Local Government Areas	Ibadan North	Ibadan	2000212	Nigeria
Schools in Ibadan North East	Ibadan North East Local Government Area	Ibadan		Nigeria
Schools in Ibadan South East	Ibadan South East Local Government Area	Ibadan		Nigeria

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Consortium for Advanced Training in Africa APHRC Kenya	Manga close off Kirawa road	Nairobi	00100	Kenya

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	CARTA	Manga close, off Kirawa street	Nairobi	0100	Kenya	Funding Agency

COLLABORATORS
Name	Street address	City	Postal code	Country
Professor Gbemisola A. Oke	University of Ibadan	Ibadan		Nigeria
Professor Mike T john	University of Minnesota	Minnesota		United States of America

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Folake Lawal	fblawal@hotmail.com	+2348131733311	University of Ibadan
City	Postal code	Country	Position/Affiliation
Ibadan		Nigeria	Lecturer University of Ibadan and University College Hospital Ibadan
Role	Name	Email	Phone	Street address
Public Enquiries	Folake Lawal	fblawal@hotmail.com	+2348131733311	University of Ibadan
City	Postal code	Country	Position/Affiliation
Ibadan		Nigeria	Lecturer University of Ibadan and University College Hospital Ibadan
Role	Name	Email	Phone	Street address
Scientific Enquiries	Folake Lawal	fblawal@hotmail.com	+2348131733311	University of Ibadan
City	Postal code	Country	Position/Affiliation
Ibadan		Nigeria	Lecturer University of Ibadan and University College Hospital Ibadan

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	Data obtained through this study may be provided to qualified researchers with academic interest in school oral health and dental patients reported outcomes. Data to be shared will be coded and de- identified. Approval of the request can only be granted after fulfilling all the prerequisites of sharing of data with the requesting party including execution of all applicable agreements such as a material transfer agreement	Informed Consent Form	Data requests can be submitted starting one year after article publication and the data will be made accessible for up to two years.	Access to trial IPD can be requested by qualified researchers engaging in independent scientific research. It will be provided following review and approval of a research proposal as well as Statistical Analysis Plan in addition to execution of a Data Sharing Agreement
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

Pan African Clinical Trials Registry