Evaluation of Caries Prevention Based on Genetic Etiology and Risk.

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.

Conditions

• Caries,Dental

Interventions

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.

Sponsors & Collaborators

• Vastra Gotaland Region

  collaborator OTHER_GOV

• Region Västerbotten

  collaborator OTHER_GOV

• Region Skane

  collaborator OTHER

• Region Halland

  collaborator OTHER

• Uppsala-Örebro Regional Research Council

  collaborator OTHER

• Region Östergötland

  collaborator OTHER

• Region Gävleborg

  collaborator OTHER

• County Council of Norrbotten, Sweden

  collaborator OTHER_GOV

• Västernorrland County Council, Sweden

  collaborator OTHER_GOV

• The Swedish Research Council

  collaborator OTHER_GOV

• Umeå University

  lead OTHER

Principal Investigators

• Nicklas Stromberg, Prof · Umeå University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

23 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-25

Primary Completion

2023-01-31

Completion

2025-12-31

Countries

• Sweden

Study Locations