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.: PACTR202010765421991 Date of Approval: 27/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title PROMOTING ADOLESCENT ORAL HEALTH: ASSESSING THE IMPACT OF TWO ORAL HEALTH EMPOWERMENT METHODS IN LAGOS, NIGERIA
Official scientific title PROMOTING ADOLESCENT ORAL HEALTH: ASSESSING THE IMPACT OF TWO ORAL HEALTH EMPOWERMENT METHODS IN LAGOS STATE.
Brief summary describing the background and objectives of the trial Adolescents have been reported to have poor oral hygiene and oral health.Conventional didactic oral health education teaching methods have been successful in improving oral health in the short term with little long term effect in all categories of ages.The use of social media or web technology could provide a veritable channel for changing this paradigm and sustaining gains in the long run. Objectives: 1. To assess the oral health status of adolescents at baseline. 2. To determine the level of oral health knowledge and practice among adolescents at baseline. 3. To determine the effect of didactic only versus didactic and social media reinforced oral health educational methods on the oral health knowledge and practice of adolescent school children at 1 month, six months and one year. 4. To compare the effect of didactic alone, didactic and social media reinforced oral health educational methods and no oral health education on adolescent school children's oral health after 1 month, six months and 1 year.
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 20/11/2020
Actual trial start date
Anticipated date of last follow up 20/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
Recruitment status Not yet 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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Didactic oral health education method Didactic lecture given once at the beginning of the study. once at day 1. Intervention involves delivering a one time didactic oral health education using macromodel at start of study. Assessment of oral hygiene will be done at 1 month, six months and 1 year. . 50 Active-Treatment of Control Group
Experimental Group Didactic and social media reinforced education one off didactic oral health education and three month social media follow up. Three months A didactic oral health education method at day one and a once weekly social media follow up. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adolescents whose schools have never received any oral hygiene / health educational intervention 2. Adolescent with a 2G, 3G, 4G Mobile phone that has internet facilities. 3. Children who assent and whose parents give consent. 1. Adolescents whose parents refuse to give consent. 2. Adolescents with medical condition that prevent them from being examined. Adolescent: 13 Year-18 Year 12 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 05/08/2020 Lagos University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room 107 Ist Floor, Luth Adminstrative Block, LUTH, Ishaga. Surulere 100001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Changes in the level of knowledge, attitude and preventive oral health practices of adolescents 1 month, three, Six and 1 year.
Primary Outcome Changes in oral hygiene assessed by reduction or increase in calculus accumulation. 1 month, three, six and 1 year.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Apata Memorial High School Plot 36 Godwin Omonua Street Isolo 100261 Nigeria
Oshodi High School 19 Oyetayo Street Oshodi 100261 Nigeria
Lagos city Senior Secondary School 34 Commercial Avenue, Sabo Yaba 100001 Nigeria
Prudence School Yaba 20 Mac Neil Road Yaba 100001 Nigeria
Ansar uddeen Grammer School 73 Randle Avenue Surulere 101283 Nigeria
Government College Secondary School Immam Dauda Street Surulere 101283 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
University of iowa. University of iowa, iowa, United States iowa United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of iowa iowa, United states iowa United States of America University
COLLABORATORS
Name Street address City Postal code Country
Prof Sofola Oyinkan Preventive Dentistry department, Lagos university teaching hospital. Surulere 10011 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Uyi Ekowmenhenhen Chiefidahu@gmail.com +23470304662079 Preventive Dentistry Department, Luth.
City Postal code Country Position/Affiliation
Surulere. 10011 Nigeria Senior registrar.
Role Name Email Phone Street address
Public Enquiries Oyinkan Sofola oysofola@yahoo.com +2348033031483 Preventive Dentistry Department, Luth.
City Postal code Country Position/Affiliation
Surulere. 10011 Nigeria Professor
Role Name Email Phone Street address
Scientific Enquiries Alade Lola lolaalade@live.com +2348032194138 Preventive Dentistry Department, Obafemi Awolowo University, OAU, Ife.
City Postal code Country Position/Affiliation
Ife. Nigeria Lecturer and Consultant.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I am willing to share results of my study with the research world and will make available data that has been deidentified within one year and not more than three years after completion of trial. Informed Consent Form,Statistical Analysis Plan,Study Protocol One year after completion and not more than three years after completion. Make a formal request by mail.
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