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NCT Number: NCT07761403

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

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.

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Key information

Conditions

Peri Implantitis Mouth Diseases Peri-Implantitis Periodontal Diseases Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Suleyman Demirel University Faculty of Dentistry, Department of Periodontology

Merkez, Isparta, 32260, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Functional Limitation Domain Score of the OHIP-14

    Time frame: Functional Limitation → Day 1

    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.

  2. Physical Pain Domain Score of the OHIP-14

    Time frame: Physical Pain → Day 1

    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.

  3. Physical Disability Domain Score of the OHIP-14

    Time frame: Physical Disability → Day 1

    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.

  4. Handicap Domain Score of the OHIP-14

    Time frame: Handicap → Day 1

    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.

Sponsors and collaborators

Lead sponsor

Suleyman Demirel University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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