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临床试验/NCT07761403
NCT07761403已完成不适用

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

Suleyman Demirel University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
1
主要终点
Total Oral Health Impact Profile-14 (OHIP-14) Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • 未提供

研究组 & 干预措施

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.

结局指标

主要结局

Total Oral Health Impact Profile-14 (OHIP-14) Score

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Osman Buğra Varol

Research Asistant

Suleyman Demirel University

研究点 (1)

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