Periodontal DiseaseCross-SectionNCT07545109
Evaluation of OHIP-14 and OSHIP-14 in Patients With Varying Periodontal Disease
An observational study of Periodontal Disease, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontal Disease
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 5 May 2026
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Systemically healthy individuals aged 18-65 years diagnosed with periodontitis and willing to participate in the study.
Who may be able to join
- Aged between 18 and 65 years Diagnosed with periodontitis (any stage) Willing to participate in the study and provide informed consent
Who cannot join
- Refusal to participate in the study Pregnancy or lactation Use of antibiotics or anti-inflammatory drugs within the last 3 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal University
Bolu, 14100
About this study
Official title: 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.
- Conditions
- Periodontal Disease
- Being tested
- No Interventions
- Keywords
- Periodontal disease, OHİP-14, OSHİP-14, Clinical attachment loss
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
Also called Periodontal assessment and questionnaire evaluation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: No Interventions | |
| Stage II Periodontitis (Moderate) | Participants with moderate periodontitis characterized by PPD ≤5 mm and moderate CAL without significant functional impairment or tooth loss. Receives: Other: No Interventions | |
| 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 Receives: Other: No Interventions | |
| 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. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSHİP-14
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.
Measured: One-time assessment at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Sep 2025
- Primary completion1 Mar 2026
- Study completion5 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- 300 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra ATEŞ, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545109
- Sponsor's protocol ID
- BAIBÜ
- Acronym
- Cross-Section
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of OHIP-14 and OSHIP-14 in Patients With Varying Periodontal Disease Severity and Their Relationship With Clinical Findings: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07545109
- Acronym / sponsor ID
- Cross-Section / BAIBÜ
- Conditions
- Periodontal Disease
- Keywords
- Periodontal disease, OHİP-14, OSHİP-14, Clinical attachment loss
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 5 May 2026 (estimated)
- First posted
- 22 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 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 9 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stage I Periodontitis (Mild) | – | Other: No InterventionsParticipants with mild periodontitis characterized by initial periodontal breakdown, probing pocket depth (PPD) ≤4 mm, and minimal clinical attachment loss (CAL). |
| Stage II Periodontitis (Moderate) | – | Other: No InterventionsParticipants with moderate periodontitis characterized by PPD ≤5 mm and moderate CAL without significant functional impairment or tooth loss. |
| Group 3: Stage III Periodontitis (Severe) | – | Other: No InterventionsParticipants with severe periodontitis characterized by PPD ≥6 mm, advanced CAL, furcation involvement, and increased risk of tooth loss |
| Group 4: Stage IV Periodontitis (Advanced) | – | Other: No InterventionsParticipants with advanced periodontitis characterized by extensive attachment loss, severe bone destruction, and impaired masticatory function or tooth loss. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Systemically healthy individuals aged 18-65 years diagnosed with periodontitis and willing to participate in the study.
Key inclusion criteria (1 listed)
- Aged between 18 and 65 years Diagnosed with periodontitis (any stage) Willing to participate in the study and provide informed consent
Key exclusion criteria (1 listed)
- Refusal to participate in the study Pregnancy or lactation Use of antibiotics or anti-inflammatory drugs within the last 3 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 |
|---|---|---|
| No InterventionsAlso: Periodontal assessment and questionnaire evaluationParticipants 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 | Group 3: Stage III Periodontitis (Severe), Group 4: Stage IV Periodontitis (Advanced), Stage I Periodontitis (Mild), Stage II Periodontitis (Moderate) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient privacy and confidentiality.
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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 Disease, 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 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?
This study is still under way. Results are not available in the source record yet.
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?
OSHİP-14 (time frame: One-time assessment at enrollment). 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 22 Apr 2026.