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

Sponsor

Umeå University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05600517

Collaborator

Vastra Gotaland Region (Other), Region Västerbotten (Other), Region Skane (Other), Region Halland (Other), Uppsala-Örebro Regional Research Council (Other), Region Östergötland (Other), Region Gävleborg (Other), County Council of Norrbotten, Sweden (Other), Västernorrland County Council, Sweden (Other), The Swedish Research Council (Other)

520

Enrollment

Location

Arms

52.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caries,Dental	Other: Fluoride	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

520 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled studyRandomized controlled study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Participant is not informed about if they are in the control or intervention group Outcome assessor are not aware of group allocation Both dentist/nurse and patient do not know the genotype or risk group. Caries registration at start and end will be performed by a dentist not involved in giving the orthodontic treatment or prevention to each patient

Primary Purpose:

Prevention

Official Title:

Evaluation of Caries Prevention Based on Genetic Etiology and Risk: Protocol for a Multicenter Randomized Controlled and Adaptive Trial for Oral Personalized Care (PRECARIES)

Actual Study Start Date :

Aug 25, 2021

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard prevention fluoride P4+ 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.
Experimental: Intensive prevention P4+ a patient-centered education on diet, oral hygiene and fluoridated toothpaste 5000ppm with check up´s and topical fluoride application (varnish) every second month.	Other: 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.
No Intervention: Standard prevention fluoride P4- 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.
Experimental: Intensive prevention P4- a patient-centered education on diet, oral hygiene and fluoridated toothpaste 5000ppm with check up´s and topical fluoride application (varnish) every second month.	Other: 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.

Outcome Measures

Primary Outcome Measures

% change in increment DeFS (decayed, enamel included and filled tooth surfaces) [6 months]
The % change in ΔDeFS caries increment over a follow up period of 6 and 24 months related to prevention.
% 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) [Baseline (0 months)]
The baseline and prospective caries scores for incidence and progression of lesions related to risk group
DFS (decayed and filled tooth surfaces) and DeFS (decayed, enamel included and filled tooth surfaces) [6 months]
The baseline and prospective caries scores for incidence and progression of lesions related to risk group
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

Gingival inflammation [Baseline (0 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
Gingival inflammation [6 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
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 [Baseline (0 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.
Mineralization disorders [6 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.
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.

Other Outcome Measures

Life style variables [Baseline (0 months)]
Sociodemographic data (sex and ethnicity), oral hygiene, intake frequency of sweets (e.g., cookies, biscuits, ice cream or dried fruit) and sugary drinks (never, once per month, once per week, several times per week, once per day, several times per day), and the use of extra fluoride
Life style variables [24 months]
Sociodemographic data (sex and ethnicity), oral hygiene, intake frequency of sweets (e.g., cookies, biscuits, ice cream or dried fruit) and sugary drinks (never, once per month, once per week, several times per week, once per day, several times per day), and the use of extra fluoride
Microbiota [Baseline (0 months)]
Number and type of S. mutans
Microbiota [24 months]
Number and type of S. mutans