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Trial Title:
Evaluation of Caries Prevention Based on Genetic Etiology and Risk.
NCT ID:
NCT05600517
Condition:
Caries,Dental
Conditions: Official terms:
Dental Caries
Fluorides
Conditions: 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)
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized controlled study
Primary purpose:
Prevention
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
Intervention:
Intervention type:
Other
Intervention name:
Fluoride
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.
Arm group label:
Intensive prevention P4+
Arm group label:
Intensive prevention P4-
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.
Criteria for 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
Gender:
All
Minimum age:
13 Years
Maximum age:
23 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Umeå University Hospital
Address:
City:
Umeå
Zip:
90188
Country:
Sweden
Status:
Recruiting
Start date:
August 25, 2021
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Umeå University
Agency class:
Other
Collaborator:
Agency:
Vastra Gotaland Region
Agency class:
Other
Collaborator:
Agency:
Region Västerbotten
Agency class:
Other
Collaborator:
Agency:
Region Skane
Agency class:
Other
Collaborator:
Agency:
Region Halland
Agency class:
Other
Collaborator:
Agency:
Uppsala-Örebro Regional Research Council
Agency class:
Other
Collaborator:
Agency:
Region Östergötland
Agency class:
Other
Collaborator:
Agency:
Region Gävleborg
Agency class:
Other
Collaborator:
Agency:
County Council of Norrbotten, Sweden
Agency class:
Other
Collaborator:
Agency:
Västernorrland County Council, Sweden
Agency class:
Other
Collaborator:
Agency:
The Swedish Research Council
Agency class:
Other
Source:
Umeå University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05600517
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5832611/
