Abstract
Background
About 40 to 90% of adolescents in most Low to Middle-Income Countries (LMICs) are affected by dental caries and periodontal diseases affect. 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 to cater for preventive and curative care. 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 study aims 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.
Methods
Cluster-Randomized Controlled Field Trial with two arms. All the 2 groups were examined at baseline then randomly allocated into intervention and comparator arms. The Intervention arm received modified BPOC plus oral health education while the comparator group continued with the available standard of oral care in Zambia. Modified BPOC package includes; a reminder on 5 key oral health preventive messages in a dose of once every two weeks by a trained peer (fellow student), filling of teeth which could be restored by hand instruments only using glass ionomer cement, provision of affordable toothpaste and extraction of teeth beyond restorative care. We hypothesized that modified BPOC is superior to the standard of care among 10-19 years old adolescents in reducing gingivitis and tooth decay and improving oral health-related quality of life at 12, 18, and 24 months. The primary outcome measure will include improvement of the health of gums and teeth while the secondary outcome will be an improvement in oral health-related knowledge and quality of life. The analysis will be done by intention to treat where the initial and follow-up proportions of adolescents with gum diseases (gingivitis) and tooth decay will be recorded and the relative risk ratio calculated to check if the intervention is protective.
Ethical consideration
The ethical approvals for the study were granted by three ethical boards of the hosting institutions; Copperbelt university via Tropical Diseases Research Control Institute (TDRC), Zambia (IRB 00002911 FWA 00003729), MUHAS via MUHAS Institutional Review Board (P. MUHAS-REC-4-2020-208), Tanzania, and University of Bergen via Regional Ethical Committee vest (191836), Norway. Permission to conduct research was granted by Zambia National Health Research Authority (NHRA), Copperbelt Provincial Health Directorate, and District Education Board Secretaries (DEBS). Participation was on a voluntary basis and only assented adolescents whose parents agreed and signed informed written consent were enrolled. Data collected remained anonymous and confidential as only ID numbers were recorded on the collection tools. Preventive measures against COVID 19 were adhered to during baseline data collection and intervention and will be adhered to throughout the study period.
Quality Assurance
Standard operating procedures and regulations regarding conducting oral health research and treatment have been followed. The study procedures followed National Health Research Authority (NHRA), Ministry of Health (MOH) Zambia, and World Health Organisation Oral Health Survey Protocols guidelines.
Funding
The study is partially funded by the Copperbelt University, Zambia