Clinical trial · Interventional
Evaluation of Caries Prevention Based on Genetic Etiology and Risk.
Evaluation of Caries Prevention Based on Genetic Etiology and Risk: Protocol for a Multicenter Randomized Controlled and Adaptive Trial for Oral Personalized Care (PRECARIES)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Caries,Dental | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluoride | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Standard prevention fluoride P4+
- description
- self-care prevention on diet, oral hygiene and fluoridated toothpaste 1450 ppm with checkup every second month with one occasion of fluoride varnish at the clinic.
- type
- EXPERIMENTAL
- label
- Intensive prevention P4+
- description
- a patient-centered education on diet, oral hygiene and fluoridated toothpaste 5000ppm with check up´s and topical fluoride application (varnish) every second month.
- interventionNames
- Other: Fluoride
- type
- NO_INTERVENTION
- label
- Standard prevention fluoride P4-
- description
- self-care prevention on diet, oral hygiene and fluoridated toothpaste 1450 ppm with checkup every second month with one occasion of fluoride varnish at the clinic.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
- Maximum age
- 23 Years
Show eligibility criteria text
Inclusion Criteria: \- undergoing orthodontic treatment with fixed multibrackets appliance in the upper and lower arch Exclusion Criteria: * impacted canines * agenesis in the frontal region * maxillofacial surgery
References
Publications (1)
- RESULTStromberg N, Esberg A, Sheng N, Marell L, Lofgren-Burstrom A, Danielsson K, Kallestal C. Genetic- and Lifestyle-dependent Dental Caries Defined by the Acidic Proline-rich Protein Genes PRH1 and PRH2. EBioMedicine. 2017 Dec;26:38-46. doi: 10.1016/j.ebiom.2017.11.019. Epub 2017 Nov 22. PMID 29191562