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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Kristianstad
-
Kristianstad、Kristianstad、スウェーデン、29198
- Kristianstad University
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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:
-
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Bone fill
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Probing pocket depths changes
時間枠: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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Bleeding
時間枠: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
時間枠: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
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:Ann-Marie R Jansåker、Malmö University
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- P-I reconstructive surg 10 y
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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