Clinical trial NCT05600517: Evaluation of Caries Prevention Based on Genetic Etiology and Risk.
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caries,Dental
Keywords: caries
genetic
prevention
saliva
S. Mutans
lifestyle
microbiota
exposure
Proline rich protein gene 1 (PRH1)
Proline rich protein gene 2 (PRH2)
Deleted malignant brain tumour (DMBT-1)
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
name: Region Västerbotten
name: Region Skane
name: Region Halland
name: Uppsala-Örebro Regional Research Council
name: Region Östergötland
name: Region Gävleborg
name: County Council of Norrbotten, Sweden
name: Västernorrland County Council, Sweden
name: The Swedish Research Council
First posted: 2022-10-31
Enrollment: 520
Sex: ALL
Minimum age (years): 13
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: % change in increment DeFS (decayed, enamel included and filled tooth surfaces)
timeFrame: 6 months
measure: % change in increment DeFS (decayed, enamel included and filled tooth surfaces)
timeFrame: 24 months
measure: DFS (decayed and filled tooth surfaces) and DeFS (decayed, enamel included and filled tooth surfaces)
timeFrame: Baseline (0 months)
measure: DFS (decayed and filled tooth surfaces) and DeFS (decayed, enamel included and filled tooth surfaces)
timeFrame: 6 months
measure: DFS (decayed and filled tooth surfaces) and DeFS (decayed, enamel included and filled tooth surfaces)
timeFrame: 24 months
Secondary outcomes:
measure: Gingival inflammation
timeFrame: Baseline (0 months)
measure: Gingival inflammation
timeFrame: 6 months
measure: Gingival inflammation
timeFrame: 24 months
measure: Mineralization disorders
timeFrame: Baseline (0 months)
measure: Mineralization disorders
timeFrame: 6 months
measure: Mineralization disorders
timeFrame: 24 months
Other outcomes:
measure: Life style variables
timeFrame: Baseline (0 months)
measure: Life style variables
timeFrame: 24 months
measure: Microbiota
timeFrame: Baseline (0 months)
measure: Microbiota
timeFrame: 24 months
Locations:
city: Umeå
country: Sweden
facility: Umeå University Hospital
Study officials:
affiliation: Umeå University
name: Nicklas Stromberg, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stromberg 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.