Quality of LifeNCT05339178
Quality of Life of Periodontitis Patients Visiting Supportive Periodontal Therapy
An observational study of Quality of Life and Periodontal Diseases, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Quality of Life, Periodontal Diseases
- How many people
- 300 participants
- Where
- 1 siteAustria
- Study dates
- 10 Jan 2022to Dec 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: periodontitis patients undergoing supportive treatment
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Division of Oral Surgery, School of Dentistry, Medical University of Vienna
Vienna, 1090
Kristina Bertl
About this study
Official title: 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.
- Conditions
- Quality of Life, Periodontal Diseases
- Medical subject headings
- Periodontal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
disease specific OHRQoL (ParoQoL)
Measured: at baseline
disease specific OHRQoL (ParoQoL)
Measured: after 2.5 years
disease specific OHRQoL (ParoQoL)
Measured: after 5 years
disease specific OHRQoL (ParoQoL)
Measured: after 7.5 years
disease specific OHRQoL (ParoQoL)
Measured: after 10 years
Secondary outcomes (15)
Oral Health Impact Profile (OHIP)
Measured: at baseline
perceived stress scale (PSS)
Measured: at baseline
overall health status of the patients (EQ5D-5L)
Measured: at baseline
Oral Health Impact Profile (OHIP)
Measured: after 2.5 years
perceived stress scale (PSS)
Measured: after 2.5 years
overall health status of the patients (EQ5D-5L)
Measured: after 2.5 years
Oral Health Impact Profile (OHIP)
Measured: after 5 years
perceived stress scale (PSS)
Measured: after 5 years
overall health status of the patients (EQ5D-5L)
Measured: after 5 years
Oral Health Impact Profile (OHIP)
Measured: after 7.5 years
perceived stress scale (PSS)
Measured: after 7.5 years
overall health status of the patients (EQ5D-5L)
Measured: after 7.5 years
Oral Health Impact Profile (OHIP)
Measured: after 10 years
perceived stress scale (PSS)
Measured: after 10 years
overall health status of the patients (EQ5D-5L)
Measured: after 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start10 Jan 2022
- Primary completionDec 2032 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Bertl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339178
- Sponsor's protocol ID
- 1398/2021
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Quality of Life of Periodontitis Patients Visiting Supportive Periodontal Therapy - A Prospective Study
- ClinicalTrials.gov ID
- NCT05339178
- Acronym / sponsor ID
- 1398/2021
- Conditions
- Quality of Life, Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 21 Apr 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- periodontitis patients undergoing supportive treatment
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
disease specific OHRQoL (ParoQoL)
Time frame: at baseline
disease specific OHRQoL (ParoQoL)
Time frame: after 2.5 years
disease specific OHRQoL (ParoQoL)
Time frame: after 5 years
disease specific OHRQoL (ParoQoL)
Time frame: after 7.5 years
disease specific OHRQoL (ParoQoL)
Time frame: after 10 years
15 secondary outcomes
Oral Health Impact Profile (OHIP)
Time frame: at baseline
perceived stress scale (PSS)
Time frame: at baseline
overall health status of the patients (EQ5D-5L)
Time frame: at baseline
Oral Health Impact Profile (OHIP)
Time frame: after 2.5 years
perceived stress scale (PSS)
Time frame: after 2.5 years
overall health status of the patients (EQ5D-5L)
Time frame: after 2.5 years
Oral Health Impact Profile (OHIP)
Time frame: after 5 years
perceived stress scale (PSS)
Time frame: after 5 years
overall health status of the patients (EQ5D-5L)
Time frame: after 5 years
Oral Health Impact Profile (OHIP)
Time frame: after 7.5 years
perceived stress scale (PSS)
Time frame: after 7.5 years
overall health status of the patients (EQ5D-5L)
Time frame: after 7.5 years
Oral Health Impact Profile (OHIP)
Time frame: after 10 years
perceived stress scale (PSS)
Time frame: after 10 years
overall health status of the patients (EQ5D-5L)
Time frame: after 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Periodontal Diseases, run by Medical University of Vienna at 1 site in Austria.
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 0 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: looking for participants now, as of the sponsor's last update on 21 Apr 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristina Bertl (00436645151194, kristina.bertl@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease specific OHRQoL (ParoQoL) (time frame: at baseline). 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?
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 21 Apr 2022.