- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07678892
10 Year Follow-up on Reconstructive Bone Procedures for Peri-implantitis (periimpl10y)
10 Year Follow-up After Surgical Treatment of Peri-implantitis Using a Bone Substitute With or Without a Resorbable Membrane: A Longitudinal Study
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.
연구 개요
상태
정황
상세 설명
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.
The study aimed to provide further knowledge regarding the long-term effectiveness and stability of reconstructive peri-implantitis treatment and to investigate potential differences between the two treatment modalities.
Following surgery all patients participated in a structured supportive maintanance program with supportive periodontal therapy every third month and annual clinical evaluations.
At the 10 year follow-up examination, the implant(s) was assessed clinically and radiographically. Clinical parameters included probing pocket depht, bleeding on probing, suppuration, plaque accumulation and implant survival. Probing measurements were performed using a standardized probing force of 0.25 N with a calibrated periodontal probe.
Bleeding scores were recorded at four sites per implant using the following scale:
0=no bleeding
- bleeding point
- bleeding line
- drop of blood
Plaque accumulation was recorded as present or absent, following plaque disclosure.
To minimize examiner variability, all clinical examinations was performed by the same periodontist.
The primary outcome measures were radiographic bone fill and changes in probing pocket depth at treated implant sites. Secondary outcome measures included bleeding on probing, suppuration, plaque scores, and implant survival.
Statistical analyses were performed using parametric or non-parametric methods depending on data distribution. Statistical significance was defined as p< 0.05.
Patients received both oral and written information regarding the study and provided written informed consent prior to participation. Participation was voluntary and the participants could withdraw from the study at any time without consequences. The study had received approval from the appropiate ethical reiew authority.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Kristianstad
-
Kristianstad, Kristianstad, 스웨덴, 29198
- Kristianstad University
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
-
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Group 1
Bone reconstructive surgery with a bone graft material (Algipor) and a resorbable membrane (Osseoquest)
|
Dental implants with a diagnosis of peri-implantitis treated with reconstructive surgery and a bone graft and a membrane
|
|
Group 2
Bone reconstructive surgery with a bone graft material (Algipor)
|
Dental, implants with a diagnosis of peri.implantitis
treated with reconstructive surgery and a bone graft alone
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Bone fill
기간: 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
|
10 years after surgical reconstrucyive bone procedures
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Probing pocket depths changes
기간: 10 years after surgical reconstructive bone procedures
|
Changes in probing pocket depths at the implant measured at four sites in mm
|
10 years after surgical reconstructive bone procedures
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Bleeding
기간: 10 years after surgical reconstructive bone procedures
|
Bleeding on probing measured at the implant at four sites as present or absent
|
10 years after surgical reconstructive bone procedures
|
|
Graded bleeding
기간: 10 years after surgical reconstructive bone procedures
|
Graded bleeding measured at the implant at four sites as: 0=no bleeding 1= point of bleeding 2=line of bleeding and 3=drop of bleeding
|
10 years after surgical reconstructive bone procedures
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Ann-Marie R Jansåker, Malmö University
간행물 및 유용한 링크
일반 간행물
- Roos-Jansaker AM, Persson GR, Lindahl C, Renvert S. Surgical treatment of peri-implantitis using a bone substitute with or without a resorbable membrane: a 5-year follow-up. J Clin Periodontol. 2014 Nov;41(11):1108-14. doi: 10.1111/jcpe.12308. Epub 2014 Oct 17.
- Roos-Jansaker AM, Lindahl C, Persson GR, Renvert S. Long-term stability of surgical bone regenerative procedures of peri-implantitis lesions in a prospective case-control study over 3 years. J Clin Periodontol. 2011 Jun;38(6):590-7. doi: 10.1111/j.1600-051X.2011.01729.x. Epub 2011 Apr 13.
- Roos-Jansaker AM, Renvert H, Lindahl C, Renvert S. Surgical treatment of peri-implantitis using a bone substitute with or without a resorbable membrane: a prospective cohort study. J Clin Periodontol. 2007 Jul;34(7):625-32. doi: 10.1111/j.1600-051X.2007.01102.x.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- P-I reconstructive surg 10 y
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .