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.: PACTR202210624926299 Date of Approval: 05/10/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECTIVENESS OF MODIFIED BASIC PACKAGE OF ORAL CARE ON ORAL HEALTH STATUS AND RELATED QUALITY OF LIFE AMONG ZAMBIAN ADOLESCENTS-: A RANDOMIZED FIELD TRIAL
Official scientific title EFFECTIVENESS OF MODIFIED BASIC PACKAGE OF ORAL CARE ON ORAL HEALTH STATUS AND RELATED QUALITY OF LIFE AMONG ZAMBIAN ADOLESCENTS-: A RANDOMIZED FIELD TRIAL
Brief summary describing the background and objectives of the trial Background About 40 to 90% of adolescents in most Low to Middle-Income Countries (LMICs) are affected by dental caries and periodontal diseases. Most of the diseases remain untreated, thus impacting negatively the adolescents’ general health, well-being, and quality of life. In Sub-Saharan Africa (SSA) the diseases accumulate in socially disadvantaged adolescents in situations where the available oral health systems and services are inadequate. The cost of treating dental caries with the curative approach alone exceeds the fiscal capabilities of most LMICs including Zambia. World Health Organisation (WHO) recommended the Basic Package of Oral Care (BPOC) as a cost-effective preventive and curative approach for dental caries however, the strategy has never been tested and implemented in the Sub-Saharan Africa region, Zambia inclusive. This trial aim at assessing the effectiveness of the modified BPOC in improving oral health knowledge and related behaviors, oral health, and quality of life among Zambian Adolescents.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BPOC
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/10/2020
Actual trial start date 18/02/2021
Anticipated date of last follow up 28/02/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 1794
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Routine basic oral care None Encouraged to continue with routine oral health care but given referral when found with oral health problems 886 Uncontrolled
Experimental Group Basic Package of oral care Peer-led Oral health - once every 2 weeks Oral Urgent Treatment (OUT) simple extraction of teeth, Atraumatic Restorative Treatment (ART)-once Affordable Fluoridated Toothpastes- once every three months 6 months The trial intervention is a modified WHO –BPOC which includes all the 3 packages of BPOC plus oral health education. The first package, Oral Urgent Treatment (OUT) will include simple extraction of teeth beyond restorable conditions and referral for teeth requiring clinic set up for removal. The second package which is Atraumatic Restorative Treatment (ART) will be executed using hand instruments only by removing the decayed part of teeth with cavities not reaching the pulp or not diagnosed as irreversible pulpitis then filling with Fuji IX Glass- ionomer. The third component (Affordable Fluoridated Toothpastes) will be done by providing a 250g pack of fluoride toothpaste every two months and toothbrushes every three months for 18 months. In addition to WHO-BPOC, the study will also give peer-provided oral health education. The peer educators will be furnished with the following printed messages to deliver to their classmates in the intervention groups once after every two weeks for a period of 18 months; 1. Restrict the frequency of taking sugary food and drinks in the diet to less than five times per day. 2. Brush your teeth for 2 minutes ensuring all the surfaces are cleaned; twice per day in the morning and evening before retiring to bed. 3. Use fluoride toothpaste to brush, spit the foam but do not rinse it out. 4. Change your toothbrush every 3 months or when bristles flare out. 5. Advise your parent or guardian to buy a toothpaste containing at least 1450 ppm fluoride and to take you for a dental check-up at least once a year. 908
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Public secondary schools in Copperbelt Province Adolescents aged 10- 18 studying at secondary schools in Copperbelt province Schools involved in any other oral health intervention programs Special need schools Adolescents with anodontia, Adolescents with severe dental fluorosis, Adolescents who have received orthodontic treatment Adolescents with special needs. Adolescent: 13 Year-18 Year 10 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 23/10/2020 Tropical Diseases Research Centre
Ethics Committee Address
Street address City Postal code Country
Ndola Teaching Hospital Ndola 50100 Zambia
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 29/12/2020 REK Norway
Ethics Committee Address
Street address City Postal code Country
Hauklandsveien 28 Bergen 5009 Norway
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 21/07/2020 MUHAS ETHICS COMMITEE
Ethics Committee Address
Street address City Postal code Country
UPANGA Dar es Salaam 11102 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Dental caries Baseline, 1st, 2nd and 3rd follow ups
Primary Outcome Gingivitis Baseline, 1st, 2nd and 3rd follow ups
Primary Outcome Child -Oral Health-Related Quality of Life Baseline, 1st, 2nd and 3rd follow ups
Secondary Outcome Oral hygiene Baseline, 1st, 2nd and 3rd follow ups
Secondary Outcome Oral health knowledge Baseline, 1st, 2nd and 3rd follow ups
Secondary Outcome Oral health-related behaviors Baseline, 1st, 2nd and 3rd follow ups
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chifubu Secodary School Chifubu Ndola 50100 Zambia
Targagan Secondary School Targagan Ballacks Ndola 50100 Zambia
Mpongwe day School Mpongwe Mpongwe 50100 Zambia
Kanyenda Secondary Schoool Kanyenda Mpongwe 50100 Zambia
Temweni Secondary School Chifubu Ndola 50100 Zambia
Malasha Secondary School Chifubu Ndola 50100 Zambia
Kanshenshi Secondary School Kanshenshi Ndola 50100 Zambia
Milemu Secondary School Main Masala Ndola 50100 Zambia
Masala Secondary School Main Masala Ndola 50100 Zambia
Yengwe Secoondary School Kavu Ndola 50100 Zambia
Butikiri Combined School Ibenga Masaiti 50100 Zambia
Chipulukusu Secondary School Chipulukusu Ndola 50100 Zambia
Kanini Secondary School Kanini Ndola 50100 Zambia
Kanshenshi Combined School Kanshenshi Ndola 50100 Zambia
Ibenga SDA School Ibenga Masaiti 50100 Zambia
Kawama Secondary School Kawama Ndola 50100 Zambia
Ndola stem School Dag Hammarskjold Ndola 50100 Zambia
Mupapa Secondary School Mupapa Masaiti 50100 Zambia
Fiwales Secondary School Fiwale Masaiti 50100 Zambia
Chiwala Secondary School Chiwala Ndola 50100 Zambia
Kafulafuta Kafulafuta Masaiti 50100 Zambia
Masaiti Secondary School Masaiti Boma Masaiti 50100 Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Bergen Arstadveien 19 Bergen 5009 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor University of Bergen Arstadveien 19 Bergen 5009 Norway University
COLLABORATORS
Name Street address City Postal code Country
Severine N Anthony Department of Dental Clinical Sciences, Michael Chilufya Sata School of Medicine, The Copperbelt University Ndola 50100 Zambia
Febronia Kahabuka Department of Orthodontics, Paedodontics and Community Dentistry, School of Dentistry, Muhimbili University of Health and Allied Sciences Dar es Salaam 11102 United Republic of Tanzania
Hawa S Mbawalla Department of Orthodontics, Paedodontics and Community Dentistry, School of Dentistry, Muhimbili University of Health and Allied Sciences Dar es Salaam 11101 United Republic of Tanzania
Seter Siziya Department of Public Health, Michael Chilufya Sata School of Medicine, The Copperbelt University Ndola 50100 Zambia
Anne N Astrom Department of Clinical Dentistry, Faculty of Medicine and Dentistry, University of Bergen Bergen 5009 Norway
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Severine Anthony anthonyerembe1975@yahoo.com +260966307828 Hilcrest
City Postal code Country Position/Affiliation
Ndola 50100 Zambia Senior Lecturer School of Medicine Copperbelt University
Role Name Email Phone Street address
Public Enquiries Seter Siziya ssiziya@gmail.com +260955752646 Hilcrest
City Postal code Country Position/Affiliation
Ndola 50100 Zambia School of Medicine Copperbelt University
Role Name Email Phone Street address
Scientific Enquiries Febronia Kahabuka febby.kahabuka@gmail.com +255754538084 Upanga
City Postal code Country Position/Affiliation
Dar es Salaam 11101 United Republic of Tanzania Professor Muhimbili University of Health and Allied Sciences
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participants' data will be available for sharing upon request and can be submitted starting 12 months after the fourth article is published and the Ph.D. Defense of the principal investigator (SA). Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact the PI ( anthonyerembe1975@yahoo.com).
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