Evaluation of Caries Prevention Based on Genetic Etiology and Risk. (PRECARIES)

Umeå University

Status: Enrolling

Conditions: Caries,Dental

Treatments: Other: Fluoride

Study type: Interventional

Funder types: Other

Identifiers

NCT05600517

Dnr 2020-02533

Details and patient eligibility

About

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.

Full 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.

Enrollment: 520 estimated patients

Sex: All

Ages: 13 to 23 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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520 participants in 4 patient groups

Standard prevention fluoride P4+

No Intervention group

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.

Intensive prevention P4+

Experimental group

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.

Treatment:

Other: Fluoride

Standard prevention fluoride P4-

No Intervention group

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.

Intensive prevention P4-

Experimental group

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.

Treatment:

Other: Fluoride