Periodontal DiseasesNCT07530978
ORAL HYGIENE, PERIODONTAL STATUS AND QUALITY OF LIFE
An observational study of Periodontal Diseases and Gingivitis, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional study aims to evaluate the relationship between oral hygiene habits, periodontal status, and oral health-related quality of life in adult individuals. A total of approximately 160 participants attending the Department of Periodontology will be included. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Gingivitis, Periodontitis
- What is being tested?
- Oral Health Assessment and OSHIP-Perio Questionnaire
- Type of treatment
- Pill or oral medicine
- How many people
- 463 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2025to 15 Jun 2026
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will consist of individuals aged 18 years and older presenting to the Department of Periodontology at Bolu Abant İzzet Baysal University Faculty of Dentistry. Participants will be classified into periodontally healthy, gingivitis, and periodontitis groups according to the 2017 classification of periodontal diseases and conditions.
Who may be able to join
- Individuals aged 18 years and older
- Patients presenting to the Department of Periodontology Individuals willing to participate and provide informed consent
Who cannot join
- Use of antibiotics or anti-inflammatory drugs within the last 3 months
- History of periodontal treatment within the last 6 months
- Pregnancy or lactation
- Individuals unable to complete the questionnaire
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Dentistry, Bolu Abant İzzet Baysal University, Department of Periodontics
Bolu, Bolu, 14100
About this study
Official title: EVALUATION OF THE EFFECT OF INDIVIDUALS' ORAL HYGIENE HABITS AND PERIODONTAL STATUS ON QUALITY OF LIFE
This cross-sectional study aims to evaluate the relationship between oral hygiene habits, periodontal status, and oral health-related quality of life in adult individuals. A total of approximately 160 participants attending the Department of Periodontology will be included. Periodontal status will be assessed using standard clinical parameters, including probing depth, clinical attachment loss, bleeding on probing, and plaque index. In addition, the Periodontal Inflamed Surface Area (PISA) will be calculated to quantify inflammatory burden. Oral health-related quality of life will be evaluated using the OSHIP-Perio questionnaire, a validated patient-reported outcome measure specific to periodontal conditions. The study will investigate the association between clinical periodontal findings, oral hygiene practices, and quality of life outcomes. The findings are expected to provide a comprehensive understanding of both clinical and patient-centered aspects of periodontal disease and contribute to improved individualized treatment approaches.
- Conditions
- Periodontal Diseases, Gingivitis, Periodontitis
- Being tested
- Oral Health Assessment and OSHIP-Perio Questionnaire
- Medical subject headings
- Periodontal Diseases, Gingivitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Health Assessment and OSHIP-Perio QuestionnaireOther
Participants will undergo a comprehensive periodontal clinical examination, including assessment of probing pocket depth (PPD), clinical attachment loss (CAL), bleeding on probing (BOP), and plaque and gingival indices. In addition, participants will complete the OSHIP-Perio questionnaire to evaluate the impact of periodontal status on oral health-related quality of life. No invasive or therapeutic intervention will be performed as part of this study.
| Study group | Role | What they receive |
|---|---|---|
| PERIODONTITIS PATIENTS | Patients with a diagnosis of periodontitis, irrespective of its stage and grade.This group will include individuals diagnosed with periodontitis, characterized by interdental clinical attachment loss (CAL) at ≥2 non-adjacent teeth and/or buccal/oral CAL ≥3 mm with pocketing >3 mm at ≥2 teeth, not attributable to non-periodontal causes.
Participants will present with increased probing pocket depths (PPD ≥4 mm), bleeding on probing (BOP), and radiographic evidence of alveolar bone loss. The diagnosis and staging of periodontitis will be established according to the criteria defined by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. Receives: Other: Oral Health Assessment and OSHIP-Perio Questionnaire | |
| GINGIVITIS PATIENTS | This group will include individuals diagnosed with gingivitis, characterized by the presence of gingival inflammation without clinical attachment loss or radiographic evidence of alveolar bone loss.
Participants will exhibit bleeding on probing (BOP) ≥10%, with probing pocket depths (PPD) ≤3 mm at all sites. The diagnosis of gingivitis will be established according to the criteria defined by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. Receives: Other: Oral Health Assessment and OSHIP-Perio Questionnaire | |
| periodontally healthy individuals | This group will consist of systemically healthy individuals presenting with clinically healthy periodontal tissues. Participants will have no clinical signs of gingival inflammation, no periodontal pocket formation, no clinical attachment loss (CAL), and no radiographic evidence of alveolar bone loss.
All individuals in this group will demonstrate probing pocket depths (PPD) ≤3 mm at all sites and bleeding on probing (BOP) <10%, in accordance with the criteria defined by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. Receives: Other: Oral Health Assessment and OSHIP-Perio Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health-related quality of life (OSHIP-Perio score)
The primary outcome is the Oral and Systemic Health Impact Profile for Periodontal Disease (OSHIP-Perio) total score obtained from a 21-item questionnaire assessing the impact of periodontal status on oral health-related quality of life.
Measured: Baseline (single visit)
Secondary outcomes (5)
Probing Pocket Depth (PPD)
Probing pocket depth (PPD) will be measured in millimeters using a calibrated periodontal probe at six sites per tooth.
Measured: Baseline (single visit)
Periodontitis Stage (2017 Classification)
Periodontitis stage will be determined according to the 2017 World Workshop Classification of Periodontal Diseases, based on clinical attachment loss, radiographic bone loss, and tooth loss.
Measured: Baseline (single visit)
Clinical Attachment Level (CAL)
Clinical attachment level (CAL) will be measured in millimeters using a periodontal probe at six sites per tooth.
Measured: Baseline (single visit)
Bleeding on Probing (BOP)
Bleeding on probing (BOP) will be assessed as the presence or absence of bleeding within 15 seconds after probing and recorded as percentage (%).
Measured: Baseline (single visit)
Periodontitis Grade (2017 Classification)
Periodontitis grade will be determined according to the 2017 World Workshop Classification, based on rate of progression, risk factors, and clinical parameters.
Measured: Baseline (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start15 Oct 2025
- Primary completion15 May 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep AKGÜL, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530978
- Sponsor's protocol ID
- BAIBU-SBF-RK-02
- Status last verified
- Sep 2026
- First submitted
- 9 Apr 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared to protect participant confidentiality. De-identified and aggregated data may be available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE EFFECT OF INDIVIDUALS' ORAL HYGIENE HABITS AND PERIODONTAL STATUS ON QUALITY OF LIFE
- ClinicalTrials.gov ID
- NCT07530978
- Acronym / sponsor ID
- BAIBU-SBF-RK-02
- Conditions
- Periodontal Diseases, Gingivitis, Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 15 Apr 2026 (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.
This cross-sectional study aims to evaluate the relationship between oral hygiene habits, periodontal status, and oral health-related quality of life in adult individuals. A total of approximately 160 participants attending the Department of Periodontology will be included. Periodontal status will be assessed using standard clinical parameters, including probing depth, clinical attachment loss, bleeding on probing, and plaque index. In addition, the Periodontal Inflamed Surface Area (PISA) will be calculated to quantify inflammatory burden. Oral health-related quality of life will be evaluated using the OSHIP-Perio questionnaire, a validated patient-reported outcome measure specific to periodontal conditions. The study will investigate the association between clinical periodontal findings, oral hygiene practices, and quality of life outcomes. The findings are expected to provide a comprehensive understanding of both clinical and patient-centered aspects of periodontal disease and contribute to improved individualized treatment approaches.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PERIODONTITIS PATIENTS | – | Other: Oral Health Assessment and OSHIP-Perio QuestionnairePatients with a diagnosis of periodontitis, irrespective of its stage and grade.This group will include individuals diagnosed with periodontitis, characterized by interdental clinical attachment loss (CAL) at ≥2 non-adjacent teeth and/or buccal/oral CAL ≥3 mm with pocketing >3 mm at ≥2 teeth, not attributable to non-periodontal causes. Participants will present with increased probing pocket depths (PPD ≥4 mm), bleeding on probing (BOP), and radiographic evidence of alveolar bone loss. The diagnosis and staging of periodontitis will be established according to the criteria defined by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. |
| GINGIVITIS PATIENTS | – | Other: Oral Health Assessment and OSHIP-Perio QuestionnaireThis group will include individuals diagnosed with gingivitis, characterized by the presence of gingival inflammation without clinical attachment loss or radiographic evidence of alveolar bone loss. Participants will exhibit bleeding on probing (BOP) ≥10%, with probing pocket depths (PPD) ≤3 mm at all sites. The diagnosis of gingivitis will be established according to the criteria defined by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. |
| periodontally healthy individuals | – | Other: Oral Health Assessment and OSHIP-Perio QuestionnaireThis group will consist of systemically healthy individuals presenting with clinically healthy periodontal tissues. Participants will have no clinical signs of gingival inflammation, no periodontal pocket formation, no clinical attachment loss (CAL), and no radiographic evidence of alveolar bone loss. All individuals in this group will demonstrate probing pocket depths (PPD) ≤3 mm at all sites and bleeding on probing (BOP) <10%, in accordance with the criteria defined by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of individuals aged 18 years and older presenting to the Department of Periodontology at Bolu Abant İzzet Baysal University Faculty of Dentistry. Participants will be classified into periodontally healthy, gingivitis, and periodontitis groups according to the 2017 classification of periodontal diseases and conditions.
Key inclusion criteria (2 listed)
- Individuals aged 18 years and older
- Patients presenting to the Department of Periodontology Individuals willing to participate and provide informed consent
Key exclusion criteria (4 listed)
- Use of antibiotics or anti-inflammatory drugs within the last 3 months
- History of periodontal treatment within the last 6 months
- Pregnancy or lactation
- Individuals unable to complete the questionnaire
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 |
|---|---|---|
| Oral Health Assessment and OSHIP-Perio QuestionnaireParticipants will undergo a comprehensive periodontal clinical examination, including assessment of probing pocket depth (PPD), clinical attachment loss (CAL), bleeding on probing (BOP), and plaque and gingival indices. In addition, participants will complete the OSHIP-Perio questionnaire to evaluate the impact of periodontal status on oral health-related quality of life. No invasive or therapeutic intervention will be performed as part of this study. | Other | GINGIVITIS PATIENTS, PERIODONTITIS PATIENTS, periodontally healthy individuals |
Primary outcome
Oral health-related quality of life (OSHIP-Perio score)
Time frame: Baseline (single visit)
The primary outcome is the Oral and Systemic Health Impact Profile for Periodontal Disease (OSHIP-Perio) total score obtained from a 21-item questionnaire assessing the impact of periodontal status on oral health-related quality of life.
5 secondary outcomes
Probing Pocket Depth (PPD)
Time frame: Baseline (single visit)
Periodontitis Stage (2017 Classification)
Time frame: Baseline (single visit)
Clinical Attachment Level (CAL)
Time frame: Baseline (single visit)
Bleeding on Probing (BOP)
Time frame: Baseline (single visit)
Periodontitis Grade (2017 Classification)
Time frame: Baseline (single visit)
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 14 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared to protect participant confidentiality. De-identified and aggregated data may be available from the corresponding author upon reasonable request.
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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?
An observational study of Periodontal Diseases and Gingivitis, run by Abant Izzet Baysal 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 2 inclusion and 4 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 14 Sep 2026. 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?
Oral health-related quality of life (OSHIP-Perio score) (time frame: Baseline (single visit)). 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 14 Sep 2026.