Controlling dental biofilm during orthodontic treatment
Environmental Factors and Microbiological Interactions in Structure of Dental Biofilm
This study is testing how different types of braces affect the bacteria in your mouth and if certain cleaning methods can help control gum problems during orthodontic treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | University of Rijeka Academic / other |
| Locations | 3 sites (Rijeka and 2 other locations) |
| Trial ID | NCT05532241 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of orthodontic appliances on the oral microbiome, particularly focusing on the control of dental biofilm and its relationship with gingivitis. It aims to compare the microbiological profiles and gingival conditions of patients exposed to metal versus non-metal orthodontic appliances. The study employs a randomized controlled design with four groups, assessing the effectiveness of mechanical and chemical biofilm control methods, including the use of chlorhexidine mouthwash. Molecular biology techniques will be utilized to analyze bacterial biomass and species composition within the biofilm.
Who should consider this trial
Good fit: Ideal candidates are individuals with malocclusion requiring orthodontic treatment and a moderate to high need for intervention.
Not a fit: Patients with neurodevelopmental disorders, intellectual disabilities, or congenital craniofacial anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of gingivitis and better orthodontic treatment outcomes.
How similar studies have performed: Previous studies have shown varying degrees of success in managing dental biofilm during orthodontic treatment, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * malocclusion with moderate or great need for orthodontic treatment (Index of Orthodontic Treatment Need grades \>=3) Exclusion Criteria: * neurodevelopmental disorders * intellectual disability * oligodontia * congenital craniofacial anomalies * orofacial clefts
Where this trial is running
Rijeka and 2 other locations
- University of Rijeka Faculty of Dental Medicine — Rijeka, Croatia (Recruiting)
- University of Rijeka, Faculty od Dental Medicine, Dental Clinic — Rijeka, Croatia (Recruiting)
- University of Rijeka, Faculty of Dental Medicine — Rijeka, Croatia (Recruiting)
Study contacts
- Study coordinator: Stjepan Spalj, PhD
- Email: stjepan.spalj@fdmri.uniri.hr
- Phone: +385916119853
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.