- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07530978
ORAL HYGIENE, PERIODONTAL STATUS AND QUALITY OF LIFE
EVALUATION OF THE EFFECT OF INDIVIDUALS' ORAL HYGIENE HABITS AND PERIODONTAL STATUS ON QUALITY OF LIFE
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Zeynep Akgül Akgul, DDS, PhD
- Phone Number: 05304253826
- Email: zeyneppakgulakgul@gmail.com
Study Locations
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Bolu
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Bolu, Bolu, Turkey (Türkiye), 14100
- Recruiting
- Faculty of Dentistry, Bolu Abant İzzet Baysal University, Department of Periodontics
-
Contact:
- Zeynep Akgul, assistant professor
- Phone Number: +905304253826
- Email: zeynepakgul@ibu.edu.tr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals aged 18 years and older
- Patients presenting to the Department of Periodontology Individuals willing to participate and provide informed consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
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.
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|
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. |
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.
|
|
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral health-related quality of life (OSHIP-Perio score)
Time Frame: Baseline (single visit)
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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.
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Baseline (single visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Probing Pocket Depth (PPD)
Time Frame: Baseline (single visit)
|
Probing pocket depth (PPD) will be measured in millimeters using a calibrated periodontal probe at six sites per tooth.
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Baseline (single visit)
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Periodontitis Stage (2017 Classification)
Time Frame: Baseline (single visit)
|
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.
|
Baseline (single visit)
|
|
Clinical Attachment Level (CAL)
Time Frame: Baseline (single visit)
|
Clinical attachment level (CAL) will be measured in millimeters using a periodontal probe at six sites per tooth.
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Baseline (single visit)
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Bleeding on Probing (BOP)
Time Frame: Baseline (single visit)
|
Bleeding on probing (BOP) will be assessed as the presence or absence of bleeding within 15 seconds after probing and recorded as percentage (%).
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Baseline (single visit)
|
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Periodontitis Grade (2017 Classification)
Time Frame: Baseline (single visit)
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Periodontitis grade will be determined according to the 2017 World Workshop Classification, based on rate of progression, risk factors, and clinical parameters.
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Baseline (single visit)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAIBU-SBF-RK-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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