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.: PACTR201502001024611 Date of Approval: 01/02/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Impact of Caregivers on School Children's Utilization of Dental Services
Official scientific title The Impact of Caregivers on School Children's Utilization of Dental Services: a cluster randomized community trial at Ibadan
Brief summary describing the background and objectives of the trial BACKGROUND: Several studies have identified that 60 - 90% of children worldwide have unmet oral health needs. These untreated oral diseases adversely impact children¿s quality of life and general health. Schools are invaluable settings to conduct dental screenings because of the rising number of children enrolled in schools. It has however been recognized that individuals, determined to be positive in screening exercises, often do not go on to access appropriate care. The proposed study is therefore, designed to assess the impact of the oral health education of the Parents and Teachers on the utilization of dental services, among school children, following a School Dental Screening exercise. It is a cluster randomized community trial. School clusters of junior secondary students in Ibadan metropolis will be randomly allocated into control and intervention groups. Dental screening will be conducted and children with oral diseases will be referred for dental care in both groups. In addition to this, an oral health education programme will be delivered at Parents-Teachers Association meetings in schools in the intervention group. OBJECTIVES: 1. To assess the unmet oral health needs in junior secondary school students in Ibadan North West Local Government Area of Oyo State at baseline, 2. To evaluate the relative effectiveness of the oral health education of parents and guardians on the utilization of oral healthcare services among school children 3. To provide evidence for a refocus in the method of oral health screening among school children in developing countries
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Dental Caries, Trauma to anterior teeth, Sepsis, Poor Oral Hygiene,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 13/10/2014
Actual trial start date 21/10/2014
Anticipated date of last follow up 19/02/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 840
Actual target sample size (number of participants) 1137
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
NHREC/05/01/2008a Ethics Committee, University of Ibadan, Ibadan
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified allocation by school type (public or private) Numbered tightly wadded up paper slips Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oral Health Eduaction of Caregivers Once 10 - 15 minutes Poster Presentation 579
Control Group School Dental Screening Once 5 - 10 minutes Screening for Dental Diseases in School Childern 558 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Junior Secondary Schools in Ibadan North West LGA Junior Secondary School Children in Ibadan North West LGA whose parents have given informed consent for the study Children who are available for baseline examination and outcome assessment Schools that do not give approval to take part in the study Special needs children especially those with physical or mental challenges Children who do not allow intra-oral examination 8 Year(s) 20 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 16/10/2014 Ethics Committee of the University of Ibadan
Ethics Committee Address
Street address City Postal code Country
Institute for Advanced Medical Research and Training, College of Medicine Ibadan 200212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of school children that utilize dental service 4 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Periodontology and Community Dentistry University College Hospital Ibadan 200212 Nigeria
Idikan Primary Oral Health Clinic University College Hospital Ibadan 200251 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Sponsored Department of Periodontology and Community Dentistry, University College Hospital Ibadan 200212 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Omolola T. ALADE Department of Periodontology and Community Dentistry, University College Hospital Ibadan 200212 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Oyo State Ministry of Education Oyo State Secretariat Ibadan 200212 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omolola Alade lolaalade@live.com +234-7069586649 Department of Periodontology and Community Dentistry, University College Hospital
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Principal Investigator
Role Name Email Phone Street address
Public Enquiries Omolola Alade lolaalade@live.com +234-7069586649 Department of Periodontology and Community Dentistry, University College Hospital
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Omolola Alade lolaalade@live.com +234-7069586649 Department of Periodontology and Community Dentistry, University College Hospital
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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