- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05339178
Quality of Life of Periodontitis Patients Visiting Supportive Periodontal Therapy
April 14, 2022 updated by: Kristina Bertl, Medical University of Vienna
Evaluation of the Quality of Life of Periodontitis Patients Visiting Supportive Periodontal Therapy - A Prospective Study
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kristina Bertl
- Phone Number: 00436645151194
- Email: kristina.bertl@meduniwien.ac.at
Study Locations
-
-
-
Vienna, Austria, 1090
- Recruiting
- Division of Oral Surgery, School of Dentistry, Medical University of Vienna
-
Contact:
- Kristina Bertl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 126 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
periodontitis patients undergoing supportive treatment
Description
Inclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
disease specific OHRQoL (ParoQoL)
Time Frame: at baseline
|
at baseline
|
|
disease specific OHRQoL (ParoQoL)
Time Frame: after 2.5 years
|
after 2.5 years
|
|
disease specific OHRQoL (ParoQoL)
Time Frame: after 5 years
|
after 5 years
|
|
disease specific OHRQoL (ParoQoL)
Time Frame: after 7.5 years
|
after 7.5 years
|
|
disease specific OHRQoL (ParoQoL)
Time Frame: after 10 years
|
after 10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Oral Health Impact Profile (OHIP)
Time Frame: at baseline
|
at baseline
|
|
perceived stress scale (PSS)
Time Frame: at baseline
|
at baseline
|
|
overall health status of the patients (EQ5D-5L)
Time Frame: at baseline
|
at baseline
|
|
Oral Health Impact Profile (OHIP)
Time Frame: after 2.5 years
|
after 2.5 years
|
|
perceived stress scale (PSS)
Time Frame: after 2.5 years
|
after 2.5 years
|
|
overall health status of the patients (EQ5D-5L)
Time Frame: after 2.5 years
|
after 2.5 years
|
|
Oral Health Impact Profile (OHIP)
Time Frame: after 5 years
|
after 5 years
|
|
perceived stress scale (PSS)
Time Frame: after 5 years
|
after 5 years
|
|
overall health status of the patients (EQ5D-5L)
Time Frame: after 5 years
|
after 5 years
|
|
Oral Health Impact Profile (OHIP)
Time Frame: after 7.5 years
|
after 7.5 years
|
|
perceived stress scale (PSS)
Time Frame: after 7.5 years
|
after 7.5 years
|
|
overall health status of the patients (EQ5D-5L)
Time Frame: after 7.5 years
|
after 7.5 years
|
|
Oral Health Impact Profile (OHIP)
Time Frame: after 10 years
|
after 10 years
|
|
perceived stress scale (PSS)
Time Frame: after 10 years
|
after 10 years
|
|
overall health status of the patients (EQ5D-5L)
Time Frame: after 10 years
|
after 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2022
Primary Completion (Anticipated)
December 1, 2032
Study Completion (Anticipated)
December 1, 2033
Study Registration Dates
First Submitted
April 8, 2022
First Submitted That Met QC Criteria
April 14, 2022
First Posted (Actual)
April 21, 2022
Study Record Updates
Last Update Posted (Actual)
April 21, 2022
Last Update Submitted That Met QC Criteria
April 14, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1398/2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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