NCT05339178

Brief Summary

The present prospective study aims to assess the QoL of periodontitis patients during supportive treatment and to relate it to periodontal health (clinical and radiographic data) and treatment stability. Follow-ups after the first cross-sectional assessment are planned after approximately 2.5, 5, 7.5, and 10 years.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
92mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Jan 2022Dec 2033

Study Start

First participant enrolled

January 10, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2032

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2033

Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

10.9 years

First QC Date

April 8, 2022

Last Update Submit

April 14, 2022

Conditions

Quality of LifePeriodontal Diseases

Outcome Measures

Primary Outcomes (5)

  • disease specific OHRQoL (ParoQoL)

    at baseline

  • disease specific OHRQoL (ParoQoL)

    after 2.5 years

  • disease specific OHRQoL (ParoQoL)

    after 5 years

  • disease specific OHRQoL (ParoQoL)

    after 7.5 years

  • disease specific OHRQoL (ParoQoL)

    after 10 years

Secondary Outcomes (15)

  • Oral Health Impact Profile (OHIP)

    at baseline

  • perceived stress scale (PSS)

    at baseline

  • overall health status of the patients (EQ5D-5L)

    at baseline

  • Oral Health Impact Profile (OHIP)

    after 2.5 years

  • perceived stress scale (PSS)

    after 2.5 years

  • +10 more secondary outcomes

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

periodontitis patients undergoing supportive treatment

You may qualify if:

  • All patients returning for supportive therapy on a regular basis after active periodontal treatment will be asked for participation if they are in supportive therapy for at least 1 year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Oral Surgery, School of Dentistry, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Central Study Contacts

Kristina Bertl

CONTACT

00436645151194kristina.bertl@meduniwien.ac.at

Study Design

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

Study Record Dates

First Submitted

April 8, 2022

First Posted

April 21, 2022

Study Start

January 10, 2022

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

December 1, 2033

Last Updated

April 21, 2022

Record last verified: 2022-04

Locations

AU(1)