RCT on Effectiveness of Oral Health Preventive Programmes in School Children in Uganda

Summary

Dental caries represents a challenge for Oral Health Services in several African Countries, like Uganda. Few studies have been reported the burden of oral health, its prevention and non-operative treatment among school children in African countries.

Aim: To assess the prevalence and risk factors of dental caries and the effectiveness of strategies to prevent and treat dental caries using a non-operative approach among children in Gulu Municipality, Uganda.

Methods: The proposal RCT is structured in three phases: 1. A descriptive cross-sectional survey to collect oral data among 610 school children selected using a multistage cluster sampling; 2. A randomized unblinded two-arm trial to assess the difference in the treatment/prevention of dental caries using non-operative means among school children in the Ugandian Gulu municipality; and 3. A comparison of oral health conditions between a group of children who will be given dental cleaning tools and followed up over time versus a control group.

The oral health status of the participants will be assessed according to WHO and ICDAS guidelines. Stata 14.0. will be used for analysis; descriptive statistics will be carried out to analyze continuous and categorical variables and chi-square test as well as independent tests for bivariate analysis and modified poisson regression. In addition, the factors associated with dental caries will be determined by linear regression models using a statistical significance level of 5% (α = 0.05).

Discussion: This trial will be the first trial conducted in Uganda assessing a school-based caries prevention programme using the WHO and ICDAS standardized international guidelines. The findings obtained will increase knowledge on oral health in Uganda school children and the effectiveness of community-based caries prevention programme in this population.

Conditions

• Dental Caries
• Dental Plaque
• Dental Diseases
• Dental Caries in Children
• Oral Disease
• Oral Manifestations

Interventions

BEHAVIORAL

Use of toothbrush/toothpaste/fluoride varnish

Children receive information about the use of toothbrush/toothpaste/fluoride varnish.

BEHAVIORAL

Education on nutrition/oral hygiene

Children receive education on nutrition/oral hygiene.

Sponsors & Collaborators

• University of Bern

  lead OTHER

Principal Investigators

• Thomas G Wolf, DDS,MA,Prof · University of Bern, Switzerland

• Guglielmo Campus, DDS,PhD,Prof · Uniersity of Bern, Switzerland

• Obaida El-Modalal, DDS · University of Bern, Switzerland

• Maria-Grazia Cagetti, DDS,PhD,Prof · University of Milan, Italy

• Hannington Baliddawa, DDS, Dr. · Uganda Dental Association, Uganda

• Dominique Corti, MD, Dr. · Corti Foundation, Uganda

• Friedrich Herbst · Academy of Dentistry International, USA

• Philippe Rusca, DDS, Dr. · University of Bern, Switzerland

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-09-01

Primary Completion

2027-09-01

Completion

2028-09-01

Countries

• Switzerland

Study Locations