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NCT06081868
RCT on Effectiveness of Oral Health Preventive Programmes in School Children in Uganda
NA trial testing Use of toothbrush/toothpaste/fluoride varnish in Dental Caries in 610 participants. Suspended.
1 September 2027
Quick facts
| Lead sponsor | University of Bern |
|---|---|
| Phase | NA |
| Status | Suspended |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 610 |
| Start date | 1 September 2023 |
| Primary completion | 1 September 2027 |
| Estimated completion | 1 September 2028 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- Use of toothbrush/toothpaste/fluoride varnish
- Education on nutrition/oral hygiene
Conditions studied
- Dental Caries — all drugs for Dental Caries →
- Dental Plaque — all drugs for Dental Plaque →
- Dental Diseases — all drugs for Dental Diseases →
- Dental Caries in Children — all drugs for Dental Caries in Children →
Sponsor
University of Bern
Who can join
Adults 5 to 17, any sex, with Dental Caries or Dental Plaque. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06081868
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06081868 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Bern
- Last refreshed: 24 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06081868.
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