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临床试验/NCT06648564
NCT06648564Enrolling By Invitation不适用

20-25 Year Follow-Up After Surgical Treatment of Peri-Implantitis Using a Bone Substitute With or Without a Resorbable Membrane: A Longitudinal Study

Kristianstad University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
20
试验地点
2
主要终点
Bone fill

研究概览

简要总结

The goal of this 20-25-year observational study is to investigate the outcomes of bone regenerative surgery in peri-implantitis. Two different techniques will be compared: surgery with a bone substitute alone and surgery with a bone substitute combined with a membrane, to determine their effectiveness and assess whether one is more effective than the other. The intention of this observational study is to learn more about the long-term effects of bone regenerative surgery in patients with peri-implantitis.

Patients will be called in for a clinical and radiographic examination of the surgically treated implant(s). Probing pocket depths, presence of pus, bleeding around the implant (s) and a radiograph of the implant (s).

To be able to compare with the 1, 3, 5 and 10 year measurements.

详细描述

The aim of this 20-25 year observational follow-up study is to investigate the outcomes of bone regenerative surgery in peri-implantitis. The study compares two approaches: Group 1: surgery with a bone substitute alone (Algipore) and Group 2: surgery with a bone substitute (Algipore) combined with a membrane (Osseoquest). Both groups received systemic antibiotics-Amoxicillin 375 mg three times a day combined with Metronidazole 400 mg twice a day for 10 days, starting the day before surgery.

The objective of this observational study is to gain insights into the long-term effects of bone regenerative surgery in patients with peri-implantitis and to determine if there is a difference.

The patients were enrolled in a strict maintenance program with supportive therapy every third months with a yearly evaluation.

In this study, patients will examined of the surgically treated implant(s) after 20-25 years. The examination will include a clinical assessment, measuring probing pocket depths at each implant to the nearest millimeter using a standardized probing force of 0.25 N (Hawe-Click Probe, Kerr Hawe SA Bioggio, Switzerland). The prevalence of pus, full-mouth bleeding on probing, and bleeding grades will be recorded around the implant(s) at four sites per tooth and implant(s) as follows: 0 = no bleeding, 1 = point of bleeding, 2 = line of bleeding, and 3 = drop of bleeding. The plaque index will be defined as either visible or not visible at the implant site using an erythrosine dye (TopDent Lifco Dental AB, Enköping, Sweden). All clinical assessments will be performed by the same periodontist (AMRJ).

Data from the clinical treatment were registered in patient records. In parallel, clinical data were documented in a study protocol and saved in a safe in accordance with standard operation procedure at the clinic.The protocol with medical records were not opened until the study was completed and only by authorized persons with access to the data in the study such as, principal investigator and statisticians.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • An implant demonstrating a progressive bone loss of ≥3 threads (≥1.8 mm) following the first year of healing
  • A vertical component needed to be present at the surgical intervention in order to justify the use of a bone augmentation procedure.
  • Bleeding on probing and/or suppuration should also be present

排除标准

  • 未提供

研究组 & 干预措施

Group 1

Bone regenerativ surgery with a bone graft material (Algipore) and a resorbable membrane (Osseoquest)

干预措施: Bone regenerative surgery with a bone graft substitute and a resorbable membrane (Procedure)

Group 2

Bone regenerativ surgery with a bone graft material (Algipore)

结局指标

主要结局

Bone fill

时间窗: Ten years after surgical regenerative boneprocedures

Radiographic bone fill measured mesial and distal at the implant on an intra oral radiograph. Measurements will be performed by a blinded radiologist.

次要结局

  • Probing pocket depths changes(Ten years after surgical regenerative boneprocedures)

研究者

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

Viveca Wallin Bengtsson

phD

Kristianstad University

研究点 (2)

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