Caries,Dental
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)
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.
Interventions
OTHERFluoride
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
Vastra Gotaland Region
Region Västerbotten
Region Skane
Region Halland
Uppsala-Örebro Regional Research Council
Region Östergötland
Region Gävleborg
County Council of Norrbotten, Sweden
Västernorrland County Council, Sweden
The Swedish Research Council
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, 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 model description
Randomized controlled study
Eligibility
Sex/Gender
ALL
Age
13 Years to 23 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Microbiota | Baseline (0 months) | Number and type of S. mutans |
Countries
Sweden
Contacts
Primary ContactNicklas Strömberg, Prof
Backup ContactAnna Westerlund, Ass Prof
Outcome results
None listed