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临床试验/NCT05618171
NCT05618171已完成不适用

Evaluation of the Patient's Pre- and Post-treatment Risk Profile Using the Peri-implantitis Risk Diagram

Berceste Guler1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
170
试验地点
1
主要终点
Evaluation of pre- and post-treatment peri-implantitis risk profiles of patients who underwent dental implant treatment at the patient level.

研究概览

简要总结

Various risk factors defined in the literature should be eliminated in order for the patient to be able to use implant-supported prostheses for a longer period of time. In the literature, such a diagram for peri-implant risk factors was first described by Heitz-Mayfield in 2020. The scheme that will determine the peri-implant risk diagram is called "Implant Disease Risk Assessment (IDRA)". This tool provides evaluation of various risk factors on a single diagram. In this study, peri-implant risk diagrams will be determined by calling the patients who have previously completed implant treatment in Kütahya University of Health Sciences Faculty of Dentistry Department of Periodontology, and the change in the risk profile assessment will be re-evaluated after the risk factors that can be eliminated are eliminated. In this study, it is aimed to predict the risk of inflammation and alveolar bone loss of the tissues around the implant that may occur in the future in patients who have undergone dental implant treatment, and to evaluate the risk profiles.

详细描述

Nowadays, dental implants are increasingly applied worldwide for the restoration of lost teeth. It is known that the survival rates of dental implant treatments are quite high, but in recent studies, the maintenance of the health of the peri-implant tissues and the satisfaction of the patient play a more important role in the success of the dental implant, not the survival. Various risk factors defined in the literature should be eliminated in order for the patient to be able to use implant-supported prostheses for a longer period of time. In the literature, a Spider Web scheme named "Perio-tools" has been defined, which evaluates the risk profile of the patient by determining the risk factors for periodontal diseases. However, such a diagram for peri-implant risk factors in the literature was first described by Heitz-Mayfield in 2020. The scheme that will determine the peri-implant risk diagram is called "Implant Disease Risk Assessment (IDRA)". This tool provides evaluation of various risk factors on a single diagram. In this study, peri-implant risk diagrams will be determined by calling the patients who have previously completed implant treatment in Kütahya University of Health Sciences Faculty of Dentistry Department of Periodontology, and the change in the risk profile assessment will be re-evaluated after the risk factors that can be eliminated are eliminated.

By using "IDRA", a tool specially developed for patients who have had dental implants in our clinic, patients will be grouped as "low-medium-high" risk according to their initial status in terms of the risk of developing peri-implantitis. Again, these patients will be re-evaluated using the "IDRA" tool 1 year after applying Phase I treatment. During this whole process, clinical and radiographic evaluations will be carried out simultaneously. Periapical radiographs will be taken from the implant periphery of the patients with the parallel long cone technique. According to the periodontal disease classification made in 2017, the diagnosis of the patients will be evaluated through panoramic radiographs and clinical measurements. Patients will undergo periodontal examination at their first visit. Keratinized gingival width, plaque index, gingival index, attachment loss, bleeding indices on probing will be taken. Peri-implant mucosa will be examined. Peri-implant health status will be recorded according to the following criteria.

The state of being healthy of peri-implant tissues; No bleeding on probing, no swelling, no hyperemia, no signs of inflammation Peri-implant mucositis; Inflammatory lesion limited to the soft tissues surrounding the dental implant and no bone loss Peri-implantitis; Bleeding on probing, presence of bone loss, distance between the most coronal part of the implant in the bone and the bone level ≥ 3mm, pocket depth ≥ 6mm on probing

Plaque index and gingival index are obtained by measuring 4 regions of a tooth (mesial, distal, buccal and lingual) with Williams periodontal probe.

Attachment loss: It is the value of the distance between a tooth and the free gingiva, based on the enamel-cementum junction, measured using a Williams periodontal probe.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be over 18
  • The condition of making dental implants in Kütahya Health Sciences University, Faculty of Dentistry, Department of Periodontology
  • Finding radiographic documentation of dental implants
  • Functioning of the implants in the mouth for at least 1 year

排除标准

  • Antibiotic use in the 3 months before the first examination
  • Patients who have not received regular implant maintenance therapy
  • Pregnant and breastfeeding women
  • Mentally retarded patients

结局指标

主要结局

Evaluation of pre- and post-treatment peri-implantitis risk profiles of patients who underwent dental implant treatment at the patient level.

时间窗: 1 year after phase 1 treatment

By using "IDRA", a tool specially developed for patients who have had dental implants in our clinic, patients will be grouped as "low-medium-high" risk according to their initial status in terms of the risk of developing peri-implantitis. Again, these patients will be re-evaluated 1 year after applying Phase I treatment using the "IDRA" tool. Evaluation will be at the patient level.

Evaluation of pre- and post-treatment peri-implantitis risk profiles at implant level in patients who have undergone dental implant treatment.

时间窗: 1 year after phase 1 treatment

By using "IDRA", a tool specially developed for patients who have had dental implants in our clinic, patients will be grouped as "low-medium-high" risk according to their initial status in terms of the risk of developing peri-implantitis. Again, these patients will be re-evaluated 1 year after applying Phase I treatment using the "IDRA" tool. Evaluation will be at the implant level.

次要结局

未报告次要终点

研究者

发起方
Berceste Guler
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Berceste Guler

Associate Professor

Kutahya Health Sciences University

研究点 (1)

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