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临床试验/NCT07678892
NCT07678892已完成不适用

10 Year Follow-up After Surgical Treatment of Peri-implantitis Using a Bone Substitute With or Without a Resorbable Membrane: A Longitudinal Study

Kristianstad University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2000年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Bone fill

研究概览

简要总结

The purpose of this 10 year observational follow-up study was to evaluate the long-term outcomes of reconstructive surgical treatment of peri-implantitis. Two treatment approaches have been compared using a bone substitute with or without a resorbable membrane.The objective was to assess their effectiveness and determine wheter one treatment strategy provided superior long-term outcomes.

Participants were invited for clinical and radiographic examinations of the previously treated implant. Clinical assessments included probing pocket depth measurements, evaluation of bleeding on probing, presence of suppuration, and radiographic assessment of peri-implant bone levels.

详细描述

The objective of this 10-year observational follow-up study was to investigate the long-term clinical and radiographic outcomes of reconstructive surgical treatment and to evaluate potential differences between two reconstructive treatment protocols.

The study population consisted of patients previously treated for per-implantitis using one of the following approaches.

Group 1: Surgical treatment using a bone substitute material (Algipor) combined with a barrier membrane (Osseoquest)

Group 2: Surgical treatment using a bone substitute materail alone (Algipor)

At the time of treatment, all patients received systemic antibiotic therapy consisting of Amoxicillin 375 mg three times daily and Metronidazole 400 mg twice daily for 10 days, initiated one day before surgery.

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 —(Adult, Older Adult)
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 reconstructive surgery with a bone graft material (Algipor) and a resorbable membrane (Osseoquest)

干预措施: Treatment with a bone graft and a membrane (Procedure)

Group 2

Bone reconstructive surgery with a bone graft material (Algipor)

干预措施: Treatment with a bone graft (Procedure)

结局指标

主要结局

Bone fill

时间窗: 10 years after surgical reconstrucyive bone procedures

Radographic bone fill measured mesial and distal in mm and percent at the implant on an intra-oral radiograph. Measurements will be performed by a blinded radiologist in mm and percent

次要结局

  • Probing pocket depths changes(10 years after surgical reconstructive bone procedures)

研究者

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

Viveca Wallin Bengtsson

Principal Investigator

Kristianstad University

研究点 (1)

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