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)

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.

Read the 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.

Conditions: Caries,Dental
Being tested: Fluoride
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)
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FluorideOther
a patient-centered education on diet, oral hygiene and fluoridated toothpaste 5000ppm with check up´s and topical fluoride application (varnish) every second month.

Study groups in NCT05600517
Study group	Role	What they receive
Standard prevention fluoride P4+	No intervention	self-care prevention on diet, oral hygiene and fluoridated toothpaste 1450 ppm with checkup every second month with one occasion of fluoride varnish at the clinic.
Intensive prevention P4+	Experimental	a patient-centered education on diet, oral hygiene and fluoridated toothpaste 5000ppm with check up´s and topical fluoride application (varnish) every second month. Receives: Other: Fluoride
Standard prevention fluoride P4-	No intervention	self-care prevention on diet, oral hygiene and fluoridated toothpaste 1450 ppm with checkup every second month with one occasion of fluoride varnish at the clinic.
Intensive prevention P4-	Experimental	a patient-centered education on diet, oral hygiene and fluoridated toothpaste 5000ppm with check up´s and topical fluoride application (varnish) every second month. Receives: Other: Fluoride

What is being measured

The primary outcome is the main question the study is designed to answer.

% change in increment DeFS (decayed, enamel included and filled tooth surfaces)
The % change in ΔDeFS caries increment over a follow up period of 6 and 24 months related to prevention.
Measured: 6 months
% change in increment DeFS (decayed, enamel included and filled tooth surfaces)
The % change in ΔDeFS caries increment over a follow up period of 6 and 24 months related to prevention.
Measured: 24 months
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
Measured: Baseline (0 months)
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
Measured: 6 months
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
Measured: 24 months

Secondary outcomes (6)

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
Measured: Baseline (0 months)
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
Measured: 6 months
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
Measured: 24 months
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.
Measured: Baseline (0 months)
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.
Measured: 6 months
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.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Aug 202131 Dec 2025

First posted31 Oct 2022
Study start25 Aug 2021
Primary completion31 Jan 2023 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Caries,DentalStudies of the same condition, open and under way.
More trials run by Umeå UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized controlled study
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 520 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05600517
Sponsor's protocol ID: Dnr 2020-02533
Acronym: PRECARIES
Status last verified: Oct 2022
First submitted: 20 Oct 2022
Last updated: 31 Oct 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Stromberg N, Esberg A, Sheng N, Marell L, Lofgren-Burstrom A, Danielsson K, Kallestal 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.2017.11.019. Epub 2017 Nov 22.
PubMed 29191562

Want to know more?

Nicklas Strömberg, Prof

+46733544395

nicklas.stromberg@umu.se

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Caries,Dental trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT05600517
Acronym / sponsor ID: PRECARIES / Dnr 2020-02533
Conditions: Caries,Dental
Keywords: caries, genetic, prevention, saliva, S. Mutans, lifestyle, microbiota, exposure
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 520 participants (estimated)
Lead sponsor: Umeå UniversityUniversity, hospital or other
Collaborators: 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
Study start: 25 Aug 2021 (actual)
Primary completion: 31 Jan 2023 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 31 Oct 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Randomized controlled study

Arm	Type	Receives
Standard prevention fluoride P4+	No intervention	–self-care prevention on diet, oral hygiene and fluoridated toothpaste 1450 ppm with checkup every second month with one occasion of fluoride varnish at the clinic.
Intensive prevention P4+	Experimental	Other: Fluoridea patient-centered education on diet, oral hygiene and fluoridated toothpaste 5000ppm with check up´s and topical fluoride application (varnish) every second month.
Standard prevention fluoride P4-	No intervention	–self-care prevention on diet, oral hygiene and fluoridated toothpaste 1450 ppm with checkup every second month with one occasion of fluoride varnish at the clinic.
Intensive prevention P4-	Experimental	Other: Fluoridea patient-centered education on diet, oral hygiene and fluoridated toothpaste 5000ppm with check up´s and topical fluoride application (varnish) every second month.

Who may qualify

Ages: 13 to 23 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

undergoing orthodontic treatment with fixed multibrackets appliance in the upper and lower arch

Key exclusion criteria (3 listed)

impacted canines
agenesis in the frontal region
maxillofacial surgery

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fluoridea patient-centered education on diet, oral hygiene and fluoridated toothpaste 5000ppm with check up´s and topical fluoride application (varnish) every second month.	Other	Intensive prevention P4+, Intensive prevention P4-

Primary outcome

% change in increment DeFS (decayed, enamel included and filled tooth surfaces)
Time frame: 6 months
The % change in ΔDeFS caries increment over a follow up period of 6 and 24 months related to prevention.
% change in increment DeFS (decayed, enamel included and filled tooth surfaces)
Time frame: 24 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)
Time frame: Baseline (0 months)
The baseline and prospective caries scores for incidence and progression of lesions related to risk group
DFS (decayed and filled tooth surfaces) and DeFS (decayed, enamel included and filled tooth surfaces)
Time frame: 6 months
The baseline and prospective caries scores for incidence and progression of lesions related to risk group
DFS (decayed and filled tooth surfaces) and DeFS (decayed, enamel included and filled tooth surfaces)
Time frame: 24 months
The baseline and prospective caries scores for incidence and progression of lesions related to risk group

6 secondary outcomes

Gingival inflammation
Time frame: Baseline (0 months)
Gingival inflammation
Time frame: 6 months
Gingival inflammation
Time frame: 24 months
Mineralization disorders
Time frame: Baseline (0 months)
Mineralization disorders
Time frame: 6 months
Mineralization disorders
Time frame: 24 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
Results publication: PubMed 29191562Stromberg N, Esberg A, Sheng N, Marell L, Lofgren-Burstrom A, Danielsson K, Kallestal 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.2017.11.019. Epub 2017 Nov 22.
E Biomedicine publicationLink provided by the sponsor.
Individual participant dataSharing planned: No

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Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nicklas Strömberg, Prof contact

+46733544395

nicklas.stromberg@umu.se

Anna Westerlund, Ass Prof contact

+46703171213

anna.westerlund@odontologi.gu.se

Nicklas Stromberg, Prof principal investigator

Umeå University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fluoride in people with Caries,Dental, run by Umeå University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nicklas Strömberg, Prof (+46733544395, nicklas.stromberg@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

% change in increment DeFS (decayed, enamel included and filled tooth surfaces) (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05600517, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.