Peri ImplantitisNCT07761403
Quality of Life and Related Factors in People With Peri-Implantitis
An observational study of Peri Implantitis, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
This single-center cross-sectional observational study evaluated oral health-related quality of life and its relationship with patient- and implant-level characteristics in adults with peri-implantitis. A total of 102 participants with 207 peri-implantitis-affected implants were included. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peri Implantitis
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2025to 21 May 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Exclusion Criteria: * Refusal to participate. * Pregnancy or lactation. * Physical or mental limitations preventing a reliable clinical examination or questionnaire completion. * Cancer. * Systemic diseases with prominent oral manifestations. * Periodontal or peri-implant treatment within the previous 6 months. * Insufficient clinical, radiographic, or questionnaire records. * Presence of pink porcelain preventing reliable access to peri-implant tissues.
Who may be able to join
- Adults aged 18 to 80 years.
- Presence of at least one implant-supported restoration in function for at least 1 year.
- Presence of at least one implant meeting the diagnostic criteria for peri-implantitis.
- Availability of clinical and radiographic records.
- Completion of the validated Turkish version of the OHIP-14 questionnaire.
- Provision of written informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleyman Demirel University Faculty of Dentistry, Department of Periodontology
Merkez, Isparta, 32260
About this study
Official title: Oral Health-Related Quality of Life and Patient- and Implant-Level Factors in Peri-Implantitis: A Cross-Sectional Study
This single-center cross-sectional observational study evaluated oral health-related quality of life and its relationship with patient- and implant-level characteristics in adults with peri-implantitis. A total of 102 participants with 207 peri-implantitis-affected implants were included.
Participants underwent clinical, radiographic, prosthetic, occlusal, periodontal, and peri-implant soft-tissue assessments. Oral health-related quality of life was evaluated using the validated Turkish version of the 14-item Oral Health Impact Profile (OHIP-14). The primary outcome was the total OHIP-14 score. Selected OHIP-14 domains, including functional limitation, physical pain, physical disability, and handicap, were evaluated as exploratory outcomes.
The study aimed to determine whether demographic, behavioral, periodontal, prosthetic, occlusal, radiographic, and peri-implant soft-tissue characteristics were associated with patient-reported oral health impact in individuals with peri-implantitis.
Read the detailed description
Consecutive adult patients presenting to the Department of Periodontology, Faculty of Dentistry, Suleyman Demirel University, between February 2025 and May 2026 were screened for eligibility. Participants were required to have at least one implant-supported restoration in function for at least one year and at least one implant meeting the study definition of peri-implantitis.
Clinical, prosthetic, occlusal, periodontal, radiographic, and peri-implant soft-tissue variables were recorded. Peri-implant probing depth, bleeding on probing, suppuration, keratinized mucosa width, soft-tissue phenotype, prosthetic design characteristics, occlusal contacts, and radiographic bone-loss measurements were evaluated. Oral health-related quality of life was assessed using the validated Turkish OHIP-14 questionnaire.
The total OHIP-14 score was defined as the primary outcome. Functional limitation, physical pain, physical disability, and handicap domain scores were evaluated as exploratory secondary outcomes. Patient-level analyses and implant-level analyses were performed separately, with implant-level analyses accounting for multiple implants contributed by the same participant.
- Conditions
- Peri Implantitis
- Keywords
- Oral health-related quality of life, OHIP-14, Peri-implantitis, Patient-reported outcome measures, Implant-supported prostheses
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants With Peri-Implantitis | Adults aged 18 to 80 years with at least one implant-supported restoration in function for at least 1 year and at least one implant meeting the study definition of peri-implantitis. Participants underwent a single cross-sectional clinical, radiographic, periodontal, prosthetic, occlusal, peri-implant soft-tissue, and OHIP-14 assessment. No intervention was assigned by the investigators. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Oral Health Impact Profile-14 (OHIP-14) Score
Oral health-related quality of life was assessed using the validated Turkish version of the 14-item Oral Health Impact Profile (OHIP-14). Each item was scored from 0 (never) to 4 (very often). Item scores were summed to obtain a total score ranging from 0 to 56, with higher scores indicating a greater negative impact of oral health conditions on quality of life.
Measured: Total OHIP-14 Score → Day 1
Secondary outcomes (4)
Functional Limitation Domain Score of the OHIP-14
Functional limitation was assessed using the corresponding domain of the validated Turkish version of the 14-item Oral Health Impact Profile (OHIP-14). Higher scores indicate a greater negative impact on oral function. This domain was evaluated as an exploratory secondary outcome.
Measured: Functional Limitation → Day 1
Physical Pain Domain Score of the OHIP-14
Physical pain was assessed using the corresponding domain of the validated Turkish version of the 14-item Oral Health Impact Profile (OHIP-14). Higher scores indicate a greater negative impact related to oral pain or discomfort. This domain was evaluated as an exploratory secondary outcome.
Measured: Physical Pain → Day 1
Physical Disability Domain Score of the OHIP-14
Physical disability was assessed using the corresponding domain of the validated Turkish version of the 14-item Oral Health Impact Profile (OHIP-14). Higher scores indicate a greater negative impact on daily physical activities related to oral health. This domain was evaluated as an exploratory secondary outcome.
Measured: Physical Disability → Day 1
Handicap Domain Score of the OHIP-14
Handicap was assessed using the corresponding domain of the validated Turkish version of the 14-item Oral Health Impact Profile (OHIP-14). Higher scores indicate a greater overall negative impact of oral health on daily life. This domain was evaluated as an exploratory secondary outcome.
Measured: Handicap → Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start10 Feb 2025
- Primary completion21 May 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri ImplantitisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osman Buğra Varol, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761403
- Sponsor's protocol ID
- SDU-PERIO-OHIP-2025-01
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in the publication, together with a data dictionary, will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health-Related Quality of Life and Patient- and Implant-Level Factors in Peri-Implantitis: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07761403
- Acronym / sponsor ID
- SDU-PERIO-OHIP-2025-01
- Conditions
- Peri Implantitis
- Keywords
- Oral health-related quality of life, OHIP-14, Peri-implantitis, Patient-reported outcome measures, Implant-supported prostheses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 12 Aug 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 single-center cross-sectional observational study evaluated oral health-related quality of life and its relationship with patient- and implant-level characteristics in adults with peri-implantitis. A total of 102 participants with 207 peri-implantitis-affected implants were included.
Participants underwent clinical, radiographic, prosthetic, occlusal, periodontal, and peri-implant soft-tissue assessments. Oral health-related quality of life was evaluated using the validated Turkish version of the 14-item Oral Health Impact Profile (OHIP-14). The primary outcome was the total OHIP-14 score. Selected OHIP-14 domains, including functional limitation, physical pain, physical disability, and handicap, were evaluated as exploratory outcomes.
The study aimed to determine whether demographic, behavioral, periodontal, prosthetic, occlusal, radiographic, and peri-implant soft-tissue characteristics were associated with patient-reported oral health impact in individuals with peri-implantitis.
Detailed description
Consecutive adult patients presenting to the Department of Periodontology, Faculty of Dentistry, Suleyman Demirel University, between February 2025 and May 2026 were screened for eligibility. Participants were required to have at least one implant-supported restoration in function for at least one year and at least one implant meeting the study definition of peri-implantitis.
Clinical, prosthetic, occlusal, periodontal, radiographic, and peri-implant soft-tissue variables were recorded. Peri-implant probing depth, bleeding on probing, suppuration, keratinized mucosa width, soft-tissue phenotype, prosthetic design characteristics, occlusal contacts, and radiographic bone-loss measurements were evaluated. Oral health-related quality of life was assessed using the validated Turkish OHIP-14 questionnaire.
The total OHIP-14 score was defined as the primary outcome. Functional limitation, physical pain, physical disability, and handicap domain scores were evaluated as exploratory secondary outcomes. Patient-level analyses and implant-level analyses were performed separately, with implant-level analyses accounting for multiple implants contributed by the same participant.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With Peri-Implantitis | – | –Adults aged 18 to 80 years with at least one implant-supported restoration in function for at least 1 year and at least one implant meeting the study definition of peri-implantitis. Participants underwent a single cross-sectional clinical, radiographic, periodontal, prosthetic, occlusal, peri-implant soft-tissue, and OHIP-14 assessment. No intervention was assigned by the investigators. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Exclusion Criteria: * Refusal to participate. * Pregnancy or lactation. * Physical or mental limitations preventing a reliable clinical examination or questionnaire completion. * Cancer. * Systemic diseases with prominent oral manifestations. * Periodontal or peri-implant treatment within the previous 6 months. * Insufficient clinical, radiographic, or questionnaire records. * Presence of pink porcelain preventing reliable access to peri-implant tissues.
Key inclusion criteria (6 listed)
- Adults aged 18 to 80 years.
- Presence of at least one implant-supported restoration in function for at least 1 year.
- Presence of at least one implant meeting the diagnostic criteria for peri-implantitis.
- Availability of clinical and radiographic records.
- Completion of the validated Turkish version of the OHIP-14 questionnaire.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Oral Health Impact Profile-14 (OHIP-14) Score
Time frame: Total OHIP-14 Score → Day 1
Oral health-related quality of life was assessed using the validated Turkish version of the 14-item Oral Health Impact Profile (OHIP-14). Each item was scored from 0 (never) to 4 (very often). Item scores were summed to obtain a total score ranging from 0 to 56, with higher scores indicating a greater negative impact of oral health conditions on quality of life.
4 secondary outcomes
Functional Limitation Domain Score of the OHIP-14
Time frame: Functional Limitation → Day 1
Physical Pain Domain Score of the OHIP-14
Time frame: Physical Pain → Day 1
Physical Disability Domain Score of the OHIP-14
Time frame: Physical Disability → Day 1
Handicap Domain Score of the OHIP-14
Time frame: Handicap → Day 1
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 12 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in the publication, together with a data dictionary, will be made available 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 Peri Implantitis, run by Suleyman Demirel 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 6 inclusion and 0 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 12 Aug 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?
Total Oral Health Impact Profile-14 (OHIP-14) Score (time frame: Total OHIP-14 Score → Day 1). 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 12 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.