- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06539364
Effects Of Different Periodontal Treatments On Quality Of Life In Patients With Periodontitis
August 6, 2024 updated by: Aliye Gerzile, Izmir Katip Celebi University
The Effect Of Surgical And Non-Surgical Periodontal Treatment On The Quality Of Life In Patients With Periodontitis.
In this study, the quality of life of patients with stage 3 grade C periodontitis who underwent surgical and non-surgical periodontal treatments was evaluated.
Patients were compared based on their quality of life using OHIP-14 and OHRQoL-UK questionnaires, as well as a VAS scale, against those who did not receive periodontal treatment, those who received only phase 1 treatment one month prior, and those who underwent periodontal surgical treatment three months prior.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Currently, the most commonly used reliable scales to measure oral health-related quality of life are the OHIP-14 (Oral Health Impact Profile) and OHRQoL-UK questionnaires.
Fifty patients with stage 3 and grade c whose clinical periodontal records (PI, GI, PD and BOP) were obtained were included in the study.
OHRQoL-UK, OHIP-14 questionnaires and VAS were applied at the first session (T1).
Initial periodontal treatment (scaling, polishing and oral hygiene education) was performed, and non-surgical periodontal treatment (root surface debridement under local anesthesia) was performed in the next session.
Three to four weeks after this treatment, patients were recalled for follow-up and all clinical indices and questionnaires were repeated (T2).
After re-evaluation, the patients were divided into a surgical group (23 patients) and a non-surgical group (27 patients).
Open flap debridement was performed in areas requiring surgery (radiologic bone loss and SCD>5mm).
Patients were recalled 12-14 weeks after surgery and all indices and questionnaires were repeated (T3).
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Çiğli
-
İzmir, Çiğli, Turkey, 35640
- Izmir Katip Çelebi University Department of Periodontology
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Literate
- Over 18 years of age
- Willing to voluntarily participate in the study
- No mental retardation or any other disorder that would impede communication
Exclusion Criteria:
- Presence of any systemic disease affecting periodontal tissues or use of medication that impacts periodontal health
- Pregnancy or lactation
- Having undergone periodontal treatment in the past 6 months
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
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: NON-SURGICAL PERIODONTAL TREATMENT
Patients included in this group underwent full-mouth scaling followed by root planning in the necessary areas.
At the 3-week follow-up session, periodontal surgery was not planned.
Periodontal records were maintained, and surveys were administered at follow-up visits.
|
Quality of life surveys were conducted with OHIP-14, OHRQoL-UK and VAS
|
|
Experimental: SURGICAL PERIODONTAL TREATMENT
Patients included in this group received full-mouth scaling followed by root planning in the necessary areas.
After a 3-week follow-up period, periodontal records were taken and surgical periodontal treatment was administered to the required areas.
Periodontal records were maintained and surveys were conducted at follow-up visits.
|
Quality of life surveys were conducted with OHIP-14, OHRQoL-UK and VAS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
obtain survey results
Time Frame: Baseline (T1), 3 weeks after non-surgical periodontal treatment (T2), and 12 weeks after surgical periodontal treatment (T3).
|
obtaining survey results to see the impact on patients' quality of life
|
Baseline (T1), 3 weeks after non-surgical periodontal treatment (T2), and 12 weeks after surgical periodontal treatment (T3).
|
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)
August 8, 2019
Primary Completion (Actual)
December 18, 2020
Study Completion (Actual)
October 5, 2021
Study Registration Dates
First Submitted
July 17, 2024
First Submitted That Met QC Criteria
August 1, 2024
First Posted (Actual)
August 6, 2024
Study Record Updates
Last Update Posted (Actual)
August 7, 2024
Last Update Submitted That Met QC Criteria
August 6, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-gokae-1095
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
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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