Caries,Dental Clinical Trial
— PRECARIESOfficial 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)
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.
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Umeå University Hospital | Umeå |
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 |
Sweden,
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
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 |
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