EFFECTIVENESS OF MODIFIED BASIC PACKAGE OF ORAL CARE ON ORAL HEALTH STATUS AND RELATED QUALITY OF LIFE AMONG ZAMBIAN ADOLESCENTS-: A RANDOMIZED FIELD TRIAL

Last registered on March 15, 2022
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Pre-Trial

Trial Information

General Information

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
RCT ID
AEARCTR-0008973
Initial registration date
March 12, 2022

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
March 15, 2022, 8:07 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Country
Zambia
Region
Copperbelt Province

Primary Investigator

Name
SEVERINE ANTHONY
Affiliation
Copperbelt University
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Other Primary Investigator(s)

PI Name
SETTER SIZIYA
PI Affiliation
Copperbelt University
Contact Investigator
PI Name
FEBRONIA KAHABUKA
PI Affiliation
Muhimbili University of Health and Allied Sciences
Contact Investigator
PI Name
Anne Nordrehaug Åstrøm
PI Affiliation
University of Bergen
Contact Investigator
PI Name
Hawa Mbawalla
PI Affiliation
Muhimbili University of Health and Allied Sciences
Contact Investigator

Additional Trial Information

Status
On going
Start date
2021-06-01
End date
2023-10-31
Keywords
Health
Additional Keywords
Atraumatic Restorative Treatment (ART), Oral Urgent Treatment (OUT), Affordable Fluoride Tooth Pastes (AFT)
JEL code(s)
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
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



External Link(s)

Registration Citation

Citation
ANTHONY, SEVERINE et al. 2022. "EFFECTIVENESS OF MODIFIED BASIC PACKAGE OF ORAL CARE ON ORAL HEALTH STATUS AND RELATED QUALITY OF LIFE AMONG ZAMBIAN ADOLESCENTS-: A RANDOMIZED FIELD TRIAL." AEA RCT Registry. March 15. https://doi.org/10.1257/rct.8973-1.0
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
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.
Intervention Start Date
2021-10-04
Intervention End Date
2023-10-31

Primary Outcomes

Primary Outcomes (end points)
The expected primary outcomes are improved oral health (reduced dental caries status and gingivitis) and Oral Health-Related Quality of Life (OHRQoL).
Primary Outcomes (explanation)
Improved oral health will be measured by a reduction in the proportion of adolescents with dental caries and gum bleeding (gingivitis)
Improved OHRQoL will be measured by a reduction in the proportion of adolescents reporting impacts of oral diseases

Secondary Outcomes

Secondary Outcomes (end points)
The secondary outcomes include improved oral hygiene (plaque score) and oral health knowledge and related behaviors
Secondary Outcomes (explanation)
Improved knowledge and behaviors will be measured by improvement in mean score on knowledge and behaviours questions

Experimental Design

Experimental Design
The experiment design is a cluster-randomized field trial involving 22 randomly selected public schools (allocation ratio 1:1) from 3 districts of Copperbelt Province, Zambia.
Experimental Design Details
The experiment design is a cluster-randomized field trial involving 22 randomly selected public schools (allocation ratio 1:1) from 3 districts of Copperbelt Province, Zambia. The three districts were randomly selected from the 10 districts of the province.
Randomization Method
Randomization was done using computer random numbers
Randomization Unit
Secondary schools in 3 randomly selected schools in Copperbelt Province, Zambia
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
22 clusters
Sample size: planned number of observations
1760
Sample size (or number of clusters) by treatment arms
11 schools control, 11 schools intervention
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
20% reduction of mean DMFT from known DMFT of 1.34 (Simushi et., al 2018) to 0.268
Supporting Documents and Materials

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IRB

Institutional Review Boards (IRBs)

IRB Name
ropical Diseases Research Control Institute (TDRC), Zambia
IRB Approval Date
2020-10-23
IRB Approval Number
IRB 00002911 FWA 00003729
IRB Name
MUHAS Institutional Review Board
IRB Approval Date
2020-06-15
IRB Approval Number
P. MUHAS-REC-4-2020-208
IRB Name
Regional Ethical Committee vest , Norway
IRB Approval Date
2020-11-10
IRB Approval Number
191836
Analysis Plan

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials