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A Randomized Clinical Trial on the Effectiveness of Oral Health Preventive Programmes in School Children in Uganda
Sponsor study identifier
interventional
610
1 country
1
Study Start
September 1, 2023
Actual (reported)Primary Completion
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2023
Actual (reported)September 6, 2023
Actual (reported)October 13, 2023
Actual (reported)September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Children will be instructed to use toothbrush/toothpaste/fluoride varnish.
Children receive individual education on nutrition/oral hygiene.
Children receive information about the use of toothbrush/toothpaste/fluoride varnish.
Children receive education on nutrition/oral hygiene.
University of Bern
Bern, 3010, Switzerland
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
First Submitted
September 6, 2023
First Posted
October 13, 2023
Study Start
September 1, 2023
Actual (reported)Primary Completion
September 1, 2027
EstimatedMean 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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 24, 2025
Record last verified: 2025-09
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Source: ClinicalTrials.gov.
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