Quality of LifeNCT06539364
Effects Of Different Periodontal Treatments On Quality Of Life In Patients With Periodontitis
A study testing Quality of life surveys were conducted in people with Quality of Life, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- Quality of life surveys were conducted
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2019to 5 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Literate
- Over 18 years of age
- Willing to voluntarily participate in the study
- No mental retardation or any other disorder that would impede communication
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Çelebi University Department of Periodontology
Izmir, Çiğli, 35640
About this study
Official title: 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.
Read the 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).
- Conditions
- Quality of Life
- Being tested
- Quality of life surveys were conducted
- Keywords
- periodontitis, quality of life, VAS, OHIP-14, OHRQoL-UK
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life surveys were conductedDiagnostic test
Quality of life surveys were conducted with OHIP-14, OHRQoL-UK and VAS
| Study group | Role | What they receive |
|---|---|---|
| NON-SURGICAL PERIODONTAL TREATMENT | Active comparator | 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. Receives: Diagnostic Test: Quality of life surveys were conducted |
| SURGICAL PERIODONTAL TREATMENT | Experimental | 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. Receives: Diagnostic Test: Quality of life surveys were conducted |
What is being measured
The primary outcome is the main question the study is designed to answer.
obtain survey results
obtaining survey results to see the impact on patients' quality of life
Measured: Baseline (T1), 3 weeks after non-surgical periodontal treatment (T2), and 12 weeks after surgical periodontal treatment (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start8 Aug 2019
- Primary completion18 Dec 2020
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- According to full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL),bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were obtained from 50 systemically healthy individuals with periodontitis and after the initial treatment repeat measurements were taken at the control session to evaluate participation in the surgical treatment group.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliye Gerzile, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539364
- Sponsor's protocol ID
- 2019-gokae-1095
- Status last verified
- Aug 2024
- First submitted
- 17 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Gerzile A, Naziker Y, Ozer E, Ertugrul AS. Impact of Surgical and Non-Surgical Periodontal Therapy on Quality of Life in Case of Periodontitis. Oral Dis. 2025 Aug;31(8):2564-2571. doi: 10.1111/odi.15316. Epub 2025 Mar 19.
PubMed 40106822
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Surgical And Non-Surgical Periodontal Treatment On The Quality Of Life In Patients With Periodontitis.
- ClinicalTrials.gov ID
- NCT06539364
- Acronym / sponsor ID
- 2019-gokae-1095
- Conditions
- Quality of Life
- Keywords
- periodontitis, quality of life, VAS, OHIP-14, OHRQoL-UK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 6 Aug 2024 (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.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- According to full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL),bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were obtained from 50 systemically healthy individuals with periodontitis and after the initial treatment repeat measurements were taken at the control session to evaluate participation in the surgical treatment group.
| Arm | Type | Receives |
|---|---|---|
| NON-SURGICAL PERIODONTAL TREATMENT | Active comparator | Diagnostic Test: Quality of life surveys were conductedPatients 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. |
| SURGICAL PERIODONTAL TREATMENT | Experimental | Diagnostic Test: Quality of life surveys were conductedPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Literate
- Over 18 years of age
- Willing to voluntarily participate in the study
- No mental retardation or any other disorder that would impede communication
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life surveys were conductedQuality of life surveys were conducted with OHIP-14, OHRQoL-UK and VAS | Diagnostic test | NON-SURGICAL PERIODONTAL TREATMENT, SURGICAL PERIODONTAL TREATMENT |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Derived from this study: PubMed 40106822Gerzile A, Naziker Y, Ozer E, Ertugrul AS. Impact of Surgical and Non-Surgical Periodontal Therapy on Quality of Life in Case of Periodontitis. Oral Dis. 2025 Aug;31(8):2564-2571. doi: 10.1111/odi.15316. Epub 2025 Mar 19.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of life surveys were conducted in people with Quality of Life, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 7 Aug 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
obtain survey results (time frame: Baseline (T1), 3 weeks after non-surgical periodontal treatment (T2), and 12 weeks after surgical periodontal treatment (T3).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06539364, which also lists 1 linked publication.
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 7 Aug 2024.