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

NCT07761403 | Completed

• 1 other identifier: SDU-PERIO-OHIP-2025-01
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri Implantitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Total OHIP-14 Score → Day 1

Secondary Outcomes (4)

• Functional Limitation Domain Score of the OHIP-14

  Functional Limitation → Day 1

• Physical Pain Domain Score of the OHIP-14

  Physical Pain → Day 1

• Physical Disability Domain Score of the OHIP-14

  Physical Disability → Day 1

• Handicap Domain Score of the OHIP-14

  Handicap → Day 1

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Suleyman Demirel University Faculty of Dentistry, Department of Periodontology

Merkez, Isparta, 32260, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asistant

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 12, 2026
• Study Start: February 10, 2025
• Primary Completion: May 21, 2026
• Study Completion: May 21, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available following publication of the study results, subject to applicable institutional data-retention requirements.
• Access Criteria: Data will be available to qualified researchers who submit a methodologically sound proposal. Requests will be reviewed by the corresponding author and the responsible institution. Access will be subject to ethical approval, institutional requirements, and execution of an appropriate data-use agreement.

Locations

TU (1)