- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07545109
Evaluation of OHIP-14 and OSHIP-14 in Patients With Varying Periodontal Disease (Cross-Section)
April 16, 2026 updated by: Esra ATEŞ, Abant Izzet Baysal University
Evaluation of OHIP-14 and OSHIP-14 in Patients With Varying Periodontal Disease Severity and Their Relationship With Clinical Findings: A Cross-Sectional Study
This study aims to evaluate periodontal health status and its impact on oral health-related quality of life by combining clinical periodontal parameters with validated patient-reported outcome measures.
Periodontal assessments included probing pocket depth (PPD), clinical attachment loss (CAL), gingival index (GI), plaque index (PI), and bleeding on probing (BOP).
Participants were further classified according to periodontal disease staging and grading.
To assess the subjective impact of periodontal conditions on daily life, the Oral Health Impact Profile-14 (OHIP-14) and its shortened version, the Oral Health Impact Profile-14 short form (OShip-14), were administered.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
300
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
-
-
-
Bolu, Turkey (Türkiye), 14100
- Bolu Abant İzzet Baysal Üniversity
-
-
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
Sampling Method
Non-Probability Sample
Study Population
Systemically healthy individuals aged 18-65 years diagnosed with periodontitis and willing to participate in the study.
Description
Inclusion Criteria:
- Aged between 18 and 65 years Diagnosed with periodontitis (any stage) Willing to participate in the study and provide informed consent
Exclusion Criteria:
- Refusal to participate in the study Pregnancy or lactation Use of antibiotics or anti-inflammatory drugs within the last 3 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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Stage I Periodontitis (Mild)
Participants with mild periodontitis characterized by initial periodontal breakdown, probing pocket depth (PPD) ≤4 mm, and minimal clinical attachment loss (CAL).
|
Participants underwent a comprehensive periodontal examination, including probing pocket depth (PPD), clinical attachment loss (CAL), gingival index (GI), plaque index (PI), and bleeding on probing (BOP) assessments.
In addition, oral health-related quality of life was evaluated using the OHIP-14 and OShip-14 questionnaires.
No therapeutic or pharmacological intervention was applied.
Other Names:
|
|
Stage II Periodontitis (Moderate)
Participants with moderate periodontitis characterized by PPD ≤5 mm and moderate CAL without significant functional impairment or tooth loss.
|
Participants underwent a comprehensive periodontal examination, including probing pocket depth (PPD), clinical attachment loss (CAL), gingival index (GI), plaque index (PI), and bleeding on probing (BOP) assessments.
In addition, oral health-related quality of life was evaluated using the OHIP-14 and OShip-14 questionnaires.
No therapeutic or pharmacological intervention was applied.
Other Names:
|
|
Group 3: Stage III Periodontitis (Severe)
Participants with severe periodontitis characterized by PPD ≥6 mm, advanced CAL, furcation involvement, and increased risk of tooth loss
|
Participants underwent a comprehensive periodontal examination, including probing pocket depth (PPD), clinical attachment loss (CAL), gingival index (GI), plaque index (PI), and bleeding on probing (BOP) assessments.
In addition, oral health-related quality of life was evaluated using the OHIP-14 and OShip-14 questionnaires.
No therapeutic or pharmacological intervention was applied.
Other Names:
|
|
Group 4: Stage IV Periodontitis (Advanced)
Participants with advanced periodontitis characterized by extensive attachment loss, severe bone destruction, and impaired masticatory function or tooth loss.
|
Participants underwent a comprehensive periodontal examination, including probing pocket depth (PPD), clinical attachment loss (CAL), gingival index (GI), plaque index (PI), and bleeding on probing (BOP) assessments.
In addition, oral health-related quality of life was evaluated using the OHIP-14 and OShip-14 questionnaires.
No therapeutic or pharmacological intervention was applied.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
OSHİP-14
Time Frame: One-time assessment at enrollment
|
OShip-14 is a 14-item short-form questionnaire designed to assess oral health-related quality of life, evaluating the physical, psychological, and social impacts of oral and dental health on daily life.
|
One-time assessment at enrollment
|
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)
September 1, 2025
Primary Completion (Actual)
March 1, 2026
Study Completion (Estimated)
May 5, 2026
Study Registration Dates
First Submitted
April 16, 2026
First Submitted That Met QC Criteria
April 16, 2026
First Posted (Actual)
April 22, 2026
Study Record Updates
Last Update Posted (Actual)
April 22, 2026
Last Update Submitted That Met QC Criteria
April 16, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAIBÜ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be shared to protect patient privacy and confidentiality.
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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