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Quality of Life and Related Factors in People With Peri-Implantitis

Oral Health-Related Quality of Life and Patient- and Implant-Level Factors in Peri-Implantitis: A Cross-Sectional Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07761403
Enrollment
102
Registered
2026-08-12
Start date
2025-02-10
Completion date
2026-05-21
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri Implantitis

Keywords

Oral health-related quality of life, OHIP-14, Peri-implantitis, Patient-reported outcome measures, Implant-supported prostheses

Brief 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. 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.

Interventions

None listed

Sponsors

Suleyman Demirel University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Total Oral Health Impact Profile-14 (OHIP-14) ScoreTotal OHIP-14 Score → Day 1Oral 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.

Secondary

MeasureTime frameDescription
Functional Limitation Domain Score of the OHIP-14Functional Limitation → Day 1Functional 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.
Physical Pain Domain Score of the OHIP-14Physical Pain → Day 1Physical 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.
Physical Disability Domain Score of the OHIP-14Physical Disability → Day 1Physical 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.
Handicap Domain Score of the OHIP-14Handicap → Day 1Handicap 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026