NCT05600517

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
520

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 31, 2022

Status Verified

October 1, 2022

Enrollment Period

1.4 years

First QC Date

October 20, 2022

Last Update Submit

October 26, 2022

Conditions

Caries,Dental

Keywords

cariesgeneticpreventionsalivaS. MutanslifestylemicrobiotaexposureProline rich protein gene 1 (PRH1)Proline rich protein gene 2 (PRH2)Deleted malignant brain tumour (DMBT-1)

Outcome Measures

Primary Outcomes (5)

  • % 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.

    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.

    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

    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

    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

    24 months

Secondary Outcomes (6)

  • Gingival inflammation

    Baseline (0 months)

  • Gingival inflammation

    6 months

  • Gingival inflammation

    24 months

  • Mineralization disorders

    Baseline (0 months)

  • Mineralization disorders

    6 months

  • +1 more secondary outcomes

Other Outcomes (4)

  • Life style variables

    Baseline (0 months)

  • Life style variables

    24 months

  • Microbiota

    Baseline (0 months)

  • +1 more other outcomes

Study Arms (4)

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.

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.

Other: Fluoride

Interventions

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.

Intensive prevention P4+Intensive prevention P4-

Eligibility Criteria

Age13 Years - 23 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • impacted canines
  • agenesis in the frontal region
  • maxillofacial surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umeå University Hospital

Umeå, 90188, Sweden

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29191562RESULT

Related Links

MeSH Terms

Conditions

Dental Caries

Interventions

Fluorides

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsHydrofluoric AcidFluorine Compounds

Study Officials

  • Nicklas Stromberg, Prof

    Umeå University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicklas Strömberg, Prof

CONTACT

+46733544395nicklas.stromberg@umu.se

Anna Westerlund, Ass Prof

CONTACT

+46703171213anna.westerlund@odontologi.gu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 31, 2022

Study Start

August 25, 2021

Primary Completion

January 31, 2023

Study Completion

December 31, 2025

Last Updated

October 31, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Clinical Study Report (10.1016/j.ebiom.2017.11.019)Access

Locations

SE(1)