Evaluation of Caries Prevention Based on Genetic Etiology and Risk.

Caries,Dental Clinical Trial

— PRECARIES  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05600517
• Other study ID #: Dnr 2020-02533
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2022
• Source: Umeå University
• Contact: Nicklas Strömberg, Prof
• Phone: +46733544395
• Email: nicklas.stromberg[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: December 31, 2025
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 23 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries

Intervention

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.

Locations

Country	Name	City	State
Sweden	Umeå University Hospital	Umeå

Sponsors (11)

Lead Sponsor	Collaborator
Umeå University	County Council of Norrbotten, Sweden, Region Gävleborg, Region Halland, Region Östergötland, Region Skane, Region Västerbotten, The Swedish Research Council, Uppsala-Örebro Regional Research Council, Västernorrland County Council, Sweden, Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Strömberg N, Esberg A, Sheng N, Mårell L, Löfgren-Burström A, Danielsson K, Källestål 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.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Life style variables	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	Baseline (0 months)
Other	Life style variables	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	24 months
Other	Microbiota	Number and type of S. mutans	Baseline (0 months)
Other	Microbiota	Number and type of S. mutans	24 months
Primary	% change in increment DeFS (decayed, enamel included and filled tooth surfaces)	The % change in ?DeFS caries increment over a follow up period of 6 and 24 months related to prevention.	6 months
Primary	% change in increment DeFS (decayed, enamel included and filled tooth surfaces)	The % change in ?DeFS caries increment over a follow up period of 6 and 24 months related to prevention.	24 months
Primary	DFS (decayed and filled tooth surfaces) and DeFS (decayed, enamel included and filled tooth surfaces)	The baseline and prospective caries scores for incidence and progression of lesions related to risk group	Baseline (0 months)
Primary	DFS (decayed and filled tooth surfaces) and DeFS (decayed, enamel included and filled tooth surfaces)	The baseline and prospective caries scores for incidence and progression of lesions related to risk group	6 months
Primary	DFS (decayed and filled tooth surfaces) and DeFS (decayed, enamel included and filled tooth surfaces)	The baseline and prospective caries scores for incidence and progression of lesions related to risk group	24 months
Secondary	Gingival inflammation	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	Baseline (0 months)
Secondary	Gingival inflammation	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	6 months
Secondary	Gingival inflammation	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	24 months
Secondary	Mineralization disorders	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.	Baseline (0 months)
Secondary	Mineralization disorders	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.	6 months
Secondary	Mineralization disorders	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.	24 months

External Links

•   E Biomedicine publication