Evaluation of Caries Prevention Based on Genetic Etiology and Risk.
- Conditions
- Caries,Dental
- Interventions
- Other: Fluoride
- Registration Number
- NCT05600517
- Lead Sponsor
- Umeå University
- Brief Summary
Dental caries affects billions of people worldwide and involves saliva immunodeficiency, commensal pathogen and exposure (lifestyle) causal subtypes of the disease. Up to 85% of adolescents in Swedish and other low prevalence populations are caries-free while the remaining 15% show high, recurrent caries activity. Accordingly, there is a lack of cost-effective risk assessment and prevention tools for personalized oral care. This randomized adaptive clinical trial (RCT) evaluates both caries prevention based on genetic etiology and risk, as a consequence of saliva immunodeficiency genes specifying individuals as susceptible or resistant to caries, and the effect of intensified versus selfcare traditional prevention on the two groups.
- Detailed Description
This is a protocol for a multicenter risk assessment and intervention study (PRECARIES) with an adaptive component. The study design comprises a prescreen of 2000 adolescents of which 520 will be included in the RCT study part with adolescents undergoing ordinary orthodontic treatment with multibrackets at the Public Dental Service. The orthodontic treatment allows for rapid caries development and improved discrimination between susceptible versus resistant individuals. The children are genotyped into two risk groups; genetic susceptible and non-susceptible children that are assigned to intensive or traditional standard prevention. The clinical outcomes will adaptively be measured at different time points (0, 6, 12 and months) as caries lesions at different teeth and surfaces using tactile, visual and X-ray bitewing, clinical photos and quantitative laser fluorescence (QLF). Secondary outcomes will be inflammation at the gingival margins and pocket depth at debonding of the orthodontic appliances. Questionaires are collected as well as biological samples; swab-dna, whole and parotid saliva and microbiota. Human and microbiota geno-and protein typing involves in and ex house platforms adaptively.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 520
- undergoing orthodontic treatment with fixed multibrackets appliance in the upper and lower arch
- impacted canines
- agenesis in the frontal region
- maxillofacial surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intensive prevention P4+ Fluoride a patient-centered education on diet, oral hygiene and fluoridated toothpaste 5000ppm with check up´s and topical fluoride application (varnish) every second month. Intensive prevention P4- Fluoride a patient-centered education on diet, oral hygiene and fluoridated toothpaste 5000ppm with check up´s and topical fluoride application (varnish) every second month.
- Primary Outcome Measures
Name Time Method % change in increment DeFS (decayed, enamel included and filled tooth surfaces) 24 months The % change in ΔDeFS caries increment over a follow up period of 6 and 24 months related to prevention.
DFS (decayed and filled tooth surfaces) and DeFS (decayed, enamel included and filled tooth surfaces) 24 months The baseline and prospective caries scores for incidence and progression of lesions related to risk group
- Secondary Outcome Measures
Name Time Method Gingival inflammation 24 months Bleeding on probing quadrant 3, Gingival inflammation will be represented by the index Bleeding on probing (BoP). BoP will be performed at the buccal surfaces in the third quadrant of the mouth approximately 21 surfaces
Mineralization disorders 24 months Mineralization disturbances in enamel, including fluorosis, molar-incisor-hypo-mineralization, amelogenesis imperfecta are noted in the clinical examinations and by viewing clinical photographs and QLF technique.
Trial Locations
- Locations (1)
Umeå University Hospital
🇸🇪Umeå, Sweden