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

NCT06081868 | Suspended

• 1 other identifier: Bernzmk20072023
• Study Type: interventional
• Target: 610
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oral health; Prevention programme; Randomized controlled trial; Sustainable healthy habits; Uganda

Outcome Measures

Primary Outcomes (9)

• Prevalence of dental caries

  The outcome will be calculated by determining the percentage of participants diagnosed with dental caries.

  Baseline

• Prevalence of dental caries

  The outcome will be calculated by determining the percentage of participants diagnosed with dental caries.

  12 months

• Prevalence of dental caries

  The outcome will be calculated by determining the percentage of participants diagnosed with dental caries.

  24 months

• Mean of dental caries

  The mean values of carious teeth/surfaces, missing teeth/surfaces, filled teeth/surfaces and mean DMFT/S will be calculated.

  Baseline

• Mean of dental caries

  The mean values of carious teeth/surfaces, missing teeth/surfaces, filled teeth/surfaces and mean DMFT/S will be calculated.

  12 months

• Mean of dental caries

  The mean values of carious teeth/surfaces, missing teeth/surfaces, filled teeth/surfaces and mean DMFT/S will be calculated.

  24 months

• Presence of dental caries after the intervention

  The outcome will be calculated by determining the percentage of participants diagnosed with dental caries. The mean values of carious teeth/surfaces, missing teeth/surfaces, filled teeth/surfaces and mean DMFT/S will be calculated.

  Baseline

• Presence of dental caries after the intervention

  The outcome will be calculated by determining the percentage of participants diagnosed with dental caries. The mean values of carious teeth/surfaces, missing teeth/surfaces, filled teeth/surfaces and mean DMFT/S will be calculated.

  12 months

• Presence of dental caries after the intervention

  The outcome will be calculated by determining the percentage of participants diagnosed with dental caries. The mean values of carious teeth/surfaces, missing teeth/surfaces, filled teeth/surfaces and mean DMFT/S will be calculated.

  24 months

Secondary Outcomes (9)

• Extent of other oral diseases

  Baseline

• Extent of other oral diseases

  12 months

• Extent of other oral diseases

  24 months

• Cost of clinical interventions

  Baseline

• Cost of clinical interventions

  12 months

Study Arms (2)

Toothbrush/toothpaste/fluoride varnish

EXPERIMENTAL

Children will be instructed to use toothbrush/toothpaste/fluoride varnish.

Behavioral: Use of toothbrush/toothpaste/fluoride varnish

Education on nutrition/oral hygiene

EXPERIMENTAL

Children receive individual education on nutrition/oral hygiene.

Behavioral: Education on nutrition/oral hygiene

Interventions

Use of toothbrush/toothpaste/fluoride varnish BEHAVIORAL

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

Toothbrush/toothpaste/fluoride varnish

Education on nutrition/oral hygiene BEHAVIORAL

Children receive education on nutrition/oral hygiene.

Education on nutrition/oral hygiene

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Enrollment in one of primary schools in Gulu Municipality
• Age between 5 and 17 years
• Staying in the area for at least six months
• Parent/guardian's willingness to give consent
• Written informed consent by participant and/or parents

You may not qualify if:

• School children who refuse to participate in the research
• Parents who refuse their children's participation
• Children with chronic diseases or systemic conditions that require differential care and follow-up

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University of Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Dental Caries; Dental Plaque; Stomatognathic Diseases; Mouth Diseases; Oral Manifestations

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Dental Deposits; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas G Wolf, DDS,MA,Prof

  University of Bern, Switzerland

  PRINCIPAL INVESTIGATOR

• Guglielmo Campus, DDS,PhD,Prof

  Uniersity of Bern, Switzerland

  PRINCIPAL INVESTIGATOR

• Obaida El-Modalal, DDS

  University of Bern, Switzerland

  STUDY DIRECTOR

• Maria-Grazia Cagetti, DDS,PhD,Prof

  University of Milan, Italy

  STUDY DIRECTOR

• Hannington Baliddawa, DDS, Dr.

  Uganda Dental Association, Uganda

  STUDY DIRECTOR

• Dominique Corti, MD, Dr.

  Corti Foundation, Uganda

  STUDY DIRECTOR

• Friedrich Herbst

  Academy of Dentistry International, USA

  STUDY DIRECTOR

• Philippe Rusca, DDS, Dr.

  University of Bern, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: October 13, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)