Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation
Surgical Reconstructive Treatment of Peri-Implantitis With or Without Simultaneous Soft Tissue Augmentation: a Multi-center Randomized Controlled Trial
The study will aim to compare two modalities in the reconstructive treatment of peri-implantitis defects. More specifically, the control group will be a reconstructive approach (xenograft bone graft granules and collagen membrane, BioOss and BioGide, Geistlich, Wolhusen). The test group will be the same, with the exception of an autologous sub-epithelial connective tissue palatal graft, sutured beneath the flap, which will be used in addition to grafting materials.
Outcomes will include CAL, PD, MR, defect resolution, PI, BoP, SUPP, surgical characteristics, and patient-reported outcome measures, including an aesthetic self-evaluation.
調査の概要
詳細な説明
The study will aim to compare two modalities in the reconstructive treatment of peri-implantitis defects.
More specifically, the control group will be a "pure" reconstructive approach (xenograft bone graft granules and resorbable collagen membrane, BioOss and BioGide, Geistlich, Wolhusen). This is in accordance with gold standard practices of reconstructive therapy of peri-implant defects.
The test group will be treated with the same approach and materials, with the exception of an autologous sub-epithelial connective tissue palatal graft, sutured beneath the flap, which will be used in addition to the grafting materials. The graft will be harvested from the homolateral palate (molar region).
Outcomes will include clinical attachment level (CAL; primary outcome), probing depth (PD), mucosal recession (MR), defect resolution (a composite outcome defined as the simultaneous absence of PD > 5 mm, bleeding on probing [BOP] and/or suppuration [SUP], and bone level changes > 0.5 mm), plaque index (PI), BOP, suppuration on probing, suppuration on palpation, surgical duration, the Early Wound Healing Index (EHI), and patient-reported outcome measures (PROMs), including aesthetic self-evaluation.
PROMs will assess patients' perception of surgery, pain intensity, perceived swelling, perceived bleeding, and analgesic intake.
Clinical measurements will be recorded at baseline and at 6, 12, 18, and 24 months. EHI will be assessed at 1 and 2 weeks postoperatively. Radiographic bone levels at 12 and 24 months will be compared with those recorded on radiographs obtained at baseline. All PROMs variables, as well as aesthetic self-evaluation, will be collected using specially designed questionnaires completed by the patients. PROMs data will be recorded at 4, 8, and 12 hours after surgery on the day of surgery (day 0), and daily from postoperative day 2 to day 7. Aesthetic self-evaluation will be recorded at baseline and at 6, 12, and 24 months postoperatively.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Roma、イタリア、00100
- George Eastman Dental Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
説明
Inclusion Criteria:
· Be able and willing to provide consent and sign the informed consent form.
- Be able and willing to comply with study procedures and follow-up appointments required by the study protocol.
- Age>18 years
- Presence of at least one implant affected with peri-implantitis, defined as the following con-dition: at least one site presenting peri-implant probing depth (PPD) >6 mm and simultane-ous presence of profuse BoP/SUP and a radiographically documented change in bone level greater than initial bone remodeling. In the likely event that a baseline radiographic image is absent, the bone level will be compared to where it would likely have been at the time of implant insertion and a difference of >3 mm from that level will be considered.
- Implants in function (i.e. loaded) for at least 1 year.
- Screw- and cement-retained suprastructures for both fixed and removable prostheses.
Exclusion Criteria:
- Compromised systemic health which contraindicates the study procedures.
- Pregnant or nursing women.
- Cigarette smoking>5 per day
- Systemic conditions compromising healing (i.e. diabetes mellitus). Patients with diabe-tes mellitus types I or II will be asked to provide information regarding their most re-cent HbA1c values. Only patients with HbA1c<7% will be enrolled.
- Patients taking medications known to interfere with gingival or bone metabolism.
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Xenograft+collagen membrane
Reconstructive approach (Xenograft+collegen membrane)
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For both arms (excluding the already included information): defect debridement, removal of debris using titanium curettes, titanium brushes on the implant surface, irrigation with saline, application of sterile cotton pellets with saline solution. Grafting with (experimental) xenograft and soft tissue, or xenograft alone (control). Suture. Specific to control group (active comparator): the peri-implant defect will be filled with xenograft, and a collagen membrane will be fitted and trimmed to the defect area. Specific to test/experimental group: same as above (for control). In addition a soft tissue graft will be harvested from the palate and sutured to the buccal flap. The entire flap will then be sutured to the lingual flap. |
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実験的：Xenograft+collagen membrane+autologous soft tissue graft
Reconstructive approach (Xenograft+collegen membrane) plus soft tissue graft (autologous, harvested as FGG)
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For both arms (excluding the already included information): defect debridement, removal of debris using titanium curettes, titanium brushes on the implant surface, irrigation with saline, application of sterile cotton pellets with saline solution. Grafting with (experimental) xenograft and soft tissue, or xenograft alone (control). Suture. Specific to control group (active comparator): the peri-implant defect will be filled with xenograft, and a collagen membrane will be fitted and trimmed to the defect area. Specific to test/experimental group: same as above (for control). In addition a soft tissue graft will be harvested from the palate and sutured to the buccal flap. The entire flap will then be sutured to the lingual flap. |
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 |
|---|---|---|
|
Clinical attachment level
時間枠：change from baseline to: 6, 12, 18, 24 months
|
linear distance (mm) from the implant platform to the bottom of the pocket
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change from baseline to: 6, 12, 18, 24 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Probing depth
時間枠：6, 12, 18, 24 months
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linear distance (mm) from the gingival margin to the bottom of the pocket
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6, 12, 18, 24 months
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Disease resolution
時間枠：6, 12, 18, 24 months
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No PD greater than or equal to 5 mm and simultaneous absence of BOP/SUP and no more than 0.5 mm change between 2 weeks and 12 and 24 months on radiograph
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6, 12, 18, 24 months
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Mucosal recession
時間枠：6, 12, 18, 24 months
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linear distance (mm) from the implant platform to the gingival margin
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6, 12, 18, 24 months
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plaque index (minimum value 0, maximum 1)
時間枠：6, 12, 18, 24 months
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binary outcome: yes/ no detected running the probe into the peri-implant sulcus
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6, 12, 18, 24 months
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profuse bleeding
時間枠：6, 12, 18, 24 months
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abundant bleeding evoked upon probing immediately after
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6, 12, 18, 24 months
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BOP
時間枠：6, 12, 18, 24 months
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bleeding upon probing: bleeding evoked upon probing after 1 second
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6, 12, 18, 24 months
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suppuration
時間枠：6, 12, 18, 24 months
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Binary: yes or no, detected upon probing or digital palpation
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6, 12, 18, 24 months
|
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Gingival thickness
時間枠：6, 12, 18, 24 months
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Measured in a horizontal direction at 1 mm from the gingival margin
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6, 12, 18, 24 months
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Radiographic bone levels
時間枠：2 weeks, 12 months, 24 months
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radiographic bone level changes between the 2 week and 12 and 24 month follow-ups
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2 weeks, 12 months, 24 months
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PROMs - Patient perception of surgery
時間枠：4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
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Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate a more positive perception of the surgical procedure.
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4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
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PROMs - Patient-reported pain intensity
時間枠：4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
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Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate greater pain intensity.
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4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
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PROMs - Patient-reported swelling
時間枠：4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
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Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate greater perceived swelling.
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4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
|
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PROMs - Patient-reported bleeding
時間枠：4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
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Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate greater perceived bleeding.
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4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
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PROMs - Analgesic consumption
時間枠：12 hours after surgery and daily from day 2 through day 7 after surgery
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Number of analgesic tablets consumed by the patient during the first postoperative week.
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12 hours after surgery and daily from day 2 through day 7 after surgery
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PROMs - aesthetic self-evaluation
時間枠：Baseline, 6 months, 12 months, and 24 months
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Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate greater satisfaction with the esthetic outcome.
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Baseline, 6 months, 12 months, and 24 months
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Early wound healing
時間枠：1 week and 2 weeks after surgery
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Wound healing scores ranging from 1 to 5 by the surgeon
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1 week and 2 weeks after surgery
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Surgical duration
時間枠：at the surgery
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The interval between the initial incision and placement of the final suture, measured in minutes.
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at the surgery
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協力者と研究者
捜査官
- 主任研究者：Luca Cordaro, MD, PhD、G. Eastman Dental Hospital Rome, Italy
出版物と役立つリンク
研究記録日
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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
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