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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Roma、意大利、00100
- George Eastman Dental Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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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实验性的：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinical attachment level
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Probing depth
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Luca Cordaro, MD, PhD、G. Eastman Dental Hospital Rome, Italy
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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