NCT04081025

Brief Summary

Oral health has improved considerably in recent decades in Sweden, as well as in other countries. However, despite great improvements with regard to periodontal disease and dental caries in recent decades, global problems still persist, and as a consequence of retaining natural teeth high up in age, the risk for oral disease increases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

5 years

First QC Date

August 31, 2019

Last Update Submit

February 14, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • Periodontal disease

    The severity of alveolar bone loss are based on bone levels at interproximal sites as seen on radiographs in the premolar and molar regions in both jaws. The diagnostic categories are (1)'no bone loss', defined as normal alveolar bone height in the molar and premolar regions (i.e., a distance ≤2 mm between the cemento-enamel junction and the alveolar bone crest (2) moderate bone loss, defined as alveolar bone loss \>2 mm but not exceeding one-third of the length of the roots, or if angular bony defects/furcation defects degree II and III are present on two to three teeth in the molar-premolar region; and (3)'severe bone loss', defined as alveolar bone loss exceeding one-third of the length of the roots, or if angular bony defects/furcation defects degree II and III are present on more than three teeth in the molar and premolar regions.

    10 years (2008-2018)

  • Periodontal disease

    The severity of alveolar bone loss are based on bone levels at interproximal sites as seen on radiographs in the premolar and molar regions in both jaws. The diagnostic categories are (1)'no bone loss', defined as normal alveolar bone height in the molar and premolar regions (i.e., a distance ≤2 mm between the cemento-enamel junction and the alveolar bone crest (2) moderate bone loss, defined as alveolar bone loss \>2 mm but not exceeding one-third of the length of the roots, or if angular bony defects/furcation defects degree II and III are present on two to three teeth in the molar-premolar region; and (3)'severe bone loss', defined as alveolar bone loss exceeding one-third of the length of the roots, or if angular bony defects/furcation defects degree II and III are present on more than three teeth in the molar and premolar regions.

    At one occasion (2018)

  • Risk factors for periodontal disease

    A questionnaire is used to assess risk factors for periodontal disease.The outcome variables is: Education: * Up to secondary school * University or college of higher learning Economy for dental care: * No limited financial resources for dental care * Limited financial resources for dental care Marital status: * Married/cohabitant * Single living Tobacco use: * Current smoker * Former smoker

    Ten years (2008-2018)

  • Dental caries

    Number of teeth with dental caries

    10 years (2008-2018)

  • Dental caries

    Number of teeth with dental caries

    At one occasion (2018)

  • Risk factors for dental caries

    Number of teeth with dental caries

    Ten years (2008-2018)

  • Oral Health Related Quality of Life

    A 9-item survey instrument (Oral Impact on Daily Performance), using a five-point Likert scale, ranging from "never" (1), "less than once a month (2), 1-2 times a month (3), 1-2 times a week (4), and "every, or nearly every day" (5) was used. The questions are as follows: "during the past 6 months, how often have problems with your mouth or teeth caused any difficulty with: * Eating and enjoying food * Speaking * Pronouncing clearly * Doing light physical activities * Cleaning teeth * Sleeping and relaxing * Smiling, laughing and showing teeth without embarrassment * Maintaining usual emotional state without being irritable * Carrying out major work or social role and enjoying contact with people

    One occasion (2018)

Study Arms (1)

Adults

Age Groups 35, 50, 65, 75 and 85

Other: EpiWux

Interventions

EpiWuxOTHER

A cross-sectional and longitudinal study including a questionnaire and a clinical examination

Also known as: Oral Health
Adults

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals in age Groups 35, 50, 65, 75 and 85 years

You may qualify if:

  • None

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kristina Edman

Falun, Dalarna County, 79129, Sweden

Location

MeSH Terms

Conditions

Periodontal DiseasesDental Caries

Interventions

Oral Health

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth DemineralizationTooth Diseases

Intervention Hierarchy (Ancestors)

HealthPopulation Characteristics

Study Officials

  • Karin Gunnars Hellgren

    Region Dalarna

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2019

First Posted

September 6, 2019

Study Start

January 1, 2018

Primary Completion

December 30, 2022

Study Completion

January 31, 2023

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations