Oral health intervention for children in Romania
Child Oral Health Pilot Programme - SmilebrightRO
This study is testing a daily tooth brushing program with fluoridated toothpaste to see if it helps reduce cavities in young children aged 3-5 in Romania.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 3 Years to 5 Years |
| Sex | All |
| Sponsor | University of Medicine and Pharmacy "Victor Babes" Timisoara Academic / other |
| Locations | 5 sites (Cluj-Napoca, Cluj and 4 other locations) |
| Trial ID | NCT06441500 on ClinicalTrials.gov |
What this trial studies
This program aims to address the high prevalence of dental caries among children in Romania by implementing a daily tooth brushing initiative. It builds on baseline data collected from a National Oral Health Survey conducted in 2019-2020, which highlighted significant oral health inequalities and the need for effective preventive measures. The study evaluates the therapeutic effects of fluoridated toothpaste as part of the intervention, focusing on children aged 3-5 years attending public nurseries. The goal is to shift from a traditional curative approach to a more preventive strategy in oral health care.
Who should consider this trial
Good fit: Ideal candidates for this program are children aged 3-5 years who are enrolled in public nurseries in Romania.
Not a fit: Children with enamel fluorosis, developmental enamel defects, or those unable to perform tooth brushing independently may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of dental caries in young children, improving their overall oral health and quality of life.
How similar studies have performed: Previous studies have indicated the effectiveness of preventive oral health programs in reducing dental caries, suggesting that this approach may yield positive results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * children aged 3-5 years attending public nurseries in Romania Exclusion Criteria: * enamel fluorosis * enamel developmental defects * incapacity to perform tooth brushing by themselves
Where this trial is running
Cluj-Napoca, Cluj and 4 other locations
- University of Medicine and Pharmacy Cluj-Napoca — Cluj-Napoca, Cluj, Romania (Recruiting)
- University of Medicine and Pharmacy Craiova — Craiova, Dolj, Romania (Recruiting)
- County School Inspectorate Iasi — Iași, Iaşi, Romania (Recruiting)
- University of Medicine and Pharmacy Targu Mures — Târgu Mureş, Mureș County, Romania (Recruiting)
- University of Medicine and Pharmacy Bucharest — Bucharest, Romania (Recruiting)
Study contacts
- Study coordinator: Ruxandra Sava-Rosianu, DMD, PhD
- Email: sava-rosianu.ruxandra@umft.ro
- Phone: 740315848
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.