Implantoplasty Versus Implant Decontamination With Erythritol Air-abrasive Device During Surgical Therapy of Peri-implantitis. Clinical, Radiographic and Microbiological Evaluation. A Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Treatment success as described by the composite outcome of probing pocket depth (PPD) ≤5 mm, absence of bleeding on probing (BoP) and/or suppuration and bone loss ≤0.5 mm between week 2 and 12 months post-surgery, at 12-month examination post-surgery
研究概览
简要总结
The purpose of the present study is to compare the 1-year clinical, radiographic and microbiological outcomes and patients' satisfaction following surgical treatment of peri-implantitis after applying two different surface modification methods. Secondarily, analysis and comparison of the microbiological results of implants diagnosed and treated for peri-implantitis with healthy implants will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General Inclusion Criteria:
- •Participants ≥ 18 years and ≤ 80 years of age
- •Non-smokers based on the patients' self-reported smoking status, defined as patients who had never smoked or had quit smoking at least 2 years ago
- •Implants in function for more than 1 year after suprastructure connection
- •Inclusion Criteria for implants diagnosed with Peri-Implantitis:
- •Presence of at least one implant diagnosed with peri-implantitis defined as presence of bleeding on probing and/or suppuration, probing pocket depth ≥6 mm and ≥3 mm of detectable bone loss after initial re-modelling
- •Absence of implant mobility
- •in participants with more than one implant, the implant with the worst clinical condition will be studied.
- •Inclusion Criteria for implants diagnosed with Peri-Implant Health:
- •Absence of peri-implant signs of inflammation (redness, swelling)
- •Lack of bleeding on probing
- •Absence of bone loss beyond crestal bone level changes resulting from initial remodeling, which should not be ≥2 mm
排除标准
- •Uncontrolled diabetes mellitus (HBA1c >7)
- •Treatment with bisphosphonates
- •Needing antibiotic prophylaxis
- •Currently pregnant or breast-feeding women
- •History of systemic administration of antibiotic treatment during the preceding 3 months
- •Systemic conditions that contraindicate treatment
- •Use of medications known to induce gingival hyperplasia
研究组 & 干预措施
Implantoplasty group
6 weeks after completion of non-surgical peri-implant therapy, participants with peri-implant probing pocket depth ≥ 5mm and presence of bleeding on probing and/or suppuration will receive resective surgical treatment. Implantoplasty will be applied as an implant surface modification method.
干预措施: Non-surgical peri-implant therapy (Procedure)
Implantoplasty group
6 weeks after completion of non-surgical peri-implant therapy, participants with peri-implant probing pocket depth ≥ 5mm and presence of bleeding on probing and/or suppuration will receive resective surgical treatment. Implantoplasty will be applied as an implant surface modification method.
干预措施: Implantoplasty (Procedure)
Erythritol Air-abrasive device group
6 weeks after completion of non-surgical peri-implant therapy, participants with peri-implant probing pocket depth ≥ 5mm and presence of bleeding on probing and/or suppuration will receive resective surgical treatment. Implant surface decontamination with an air-abrasive device with erythritol powder will be applied.
干预措施: Non-surgical peri-implant therapy (Procedure)
Erythritol Air-abrasive device group
6 weeks after completion of non-surgical peri-implant therapy, participants with peri-implant probing pocket depth ≥ 5mm and presence of bleeding on probing and/or suppuration will receive resective surgical treatment. Implant surface decontamination with an air-abrasive device with erythritol powder will be applied.
干预措施: Erythritol Air-abrasive device (Procedure)
Erythritol Air-abrasive device group
6 weeks after completion of non-surgical peri-implant therapy, participants with peri-implant probing pocket depth ≥ 5mm and presence of bleeding on probing and/or suppuration will receive resective surgical treatment. Implant surface decontamination with an air-abrasive device with erythritol powder will be applied.
干预措施: Prophylaxis (Procedure)
Control group
Participants with healthy implants will be the comparator group for the microbiological analysis.
干预措施: Prophylaxis (Procedure)
Implantoplasty group
6 weeks after completion of non-surgical peri-implant therapy, participants with peri-implant probing pocket depth ≥ 5mm and presence of bleeding on probing and/or suppuration will receive resective surgical treatment. Implantoplasty will be applied as an implant surface modification method.
干预措施: Prophylaxis (Procedure)
结局指标
主要结局
Treatment success as described by the composite outcome of probing pocket depth (PPD) ≤5 mm, absence of bleeding on probing (BoP) and/or suppuration and bone loss ≤0.5 mm between week 2 and 12 months post-surgery, at 12-month examination post-surgery
时间窗: 12 months post-surgery
The percentage of treatment success will be calculated from the total amount of treated implants. * PPD will be measured in mm as the distance from the mucosal peri-implant margin to the bottom of the probeable peri-implant pocket with a manual periodontal probe to the closest millimeter at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the targeted implants. * BoP will be assessed dichotomously (1=presence, 0=absence) within 30 seconds after probing at the mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual site of the targeted implants. * Mean change in mm in mean marginal bone level (mesial and distal) will be assessed using an image-processing software. Standardized intra-oral radiographs will be obtained at each time point using a reproducible technique. Marginal bone level will be calculated as the distance from the implant shoulder to the most coronal bone-to-implant contact.
Mean total colony forming units (CFU) counts of the bacterial species under study in targeted implants with peri-implantitis from Baseline to Week 6 after non-surgical therapy
时间窗: Baseline, Week 6 after non-surgical therapy
Mean total CFU counts from Baseline to Week 6 after non-surgical therapy will be assessed at each experimental group. Mean total CFU counts will result from microbiological analysis of subgingival samples by quantitative PCR (qPCR). Subgingival samples will be obtained with three sterile paper points from the deepest pocket of targeted implants at Baseline and at Week 6 after completion of non-surgical therapy. Detection and quantification of bacterial DNA of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum and Campylobacter rectus will be performed.
Mean total colony forming units (CFU) counts of the bacterial species under study in targeted implants with peri-implantitis from Baseline to 12 months after surgical therapy
时间窗: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery
Mean total CFU counts from Baseline to 12 months after surgical therapy will be assessed at each experimental group. Mean total CFU counts will result from microbiological analysis of subgingival samples by quantitative PCR (qPCR). Subgingival samples will be obtained with three sterile paper points from the deepest pocket of targeted implants at Baseline, 3 months post-surgery, 6 months post-surgery and 12 months post-surgery. Detection and quantification of bacterial DNA of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum and Campylobacter rectus will be performed.
Mean total colony forming units (CFU) counts of the bacterial species under study in targeted implants of the control group from Baseline to 12 months follow-up visit
时间窗: Baseline, 3 months follow-up visit, 6 months follow-up visit, 12 months follow-up visit
Mean total CFU counts from Baseline to 12 months after Baseline examination will be assessed. Mean total CFU counts will result from microbiological analysis of subgingival samples by quantitative PCR (qPCR). Subgingival samples will be obtained with three sterile paper points from the implant site with the easiest access for sampling at Baseline, 3 months follow-up visit, 6 months follow-up visit, 12 months follow-up visit. Detection and quantification of bacterial DNA of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum and Campylobacter rectus will be performed.
次要结局
- Mean peri-implant probing pocket depth from Baseline to Week 6 after non-surgical therapy(Baseline, Week 6 after non-surgical therapy)
- Percentage of sites with bleeding on probing from Baseline to Week 6 after non-surgical therapy(Baseline, Week 6 after non-surgical therapy)
- Mean peri-implant probing pocket depth from Baseline to 12 months after surgical therapy(Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery)
- Mean change from Baseline in peri-implant probing pocket depth at Week 6 after non-surgical therapy(Baseline, Week 6 after non-surgical therapy)
- Mean change from Baseline in peri-implant clinical attachment level to 12 months after surgical therapy(Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery)
- Mean change from Baseline in peri-implant recession at Week 6 after non-surgical therapy(Baseline, Week 6 after non-surgical therapy)
- Evaluation of patients' willingness to recommend the treatment on the visual analogue scale (VAS) at Week 2 post-surgery(Week 2 post-surgery)
- Evaluation of patients' willingness to recommend the treatment on the visual analogue scale (VAS) at 12 months post-surgery(12 months post-surgery)
- Mean change from Baseline in peri-implant probing pocket depth to 12 months after surgical therapy(Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery)
- Percentage of sites with bleeding on probing from Baseline to 12 months after surgical therapy(Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery)
- Change from Baseline in bleeding index score to 12 months after surgical therapy(Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery)
- Percentage of sites with suppuration on probing from Baseline to Week 6 after non-surgical therapy(Baseline, Week 6 after non-surgical therapy)
- Mean local plaque score from Baseline to 12 months after surgical therapy(Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery)
- Full mouth plaque score from Baseline to Week 6 after non-surgical therapy(Baseline, Week 6 after non-surgical therapy)
- Full mouth bleeding score from Baseline to Week 6 after non-surgical therapy(Baseline, Week 6 after non-surgical therapy)
- Full mouth bleeding score from Baseline to 12 months after surgical therapy(Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery)
- Evaluation of participants' pain on the visual analogue scale (VAS, 10cm) at 12 months post-surgery(12 months post-surgery)
- Evaluation of participants' pain during toothbrushing on the visual analogue scale (VAS, 10cm) at 12 months post-surgery(12 months post-surgery)
- Change from Baseline in bleeding index score at Week 6 after completion of non-surgical therapy(Baseline, Week 6 after non-surgical therapy)
- Mean change from Baseline in peri-implant recession to 12 months after surgical therapy(Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery)
- Full mouth plaque score from Baseline to 12 months after surgical therapy(Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery)
- Evaluation of participants' pain on the visual analogue scale (VAS, 10cm) at Week 2 post-surgery(Week 2 post-surgery)
- Number of days of analgesic consumption at Week 2 post-surgery(Week 2 post-surgery)
- Evaluation of patients' satisfaction on the visual analogue scale (VAS) at 12 months post-surgery(12 months post-surgery)
- Percentage of sites with suppuration on probing from Baseline to 12 months after surgical therapy(Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery)
- Mean change from Baseline in peri-implant clinical attachment level to Week 6 after surgical therapy(Baseline, Week 6 after non-surgical therapy)
- Mean peri-implant recession from Baseline to Week 6 after non-surgical therapy(Baseline, Week 6 after non-surgical therapy)
- Mean local plaque score from Baseline to Week 6 after non-surgical therapy(Baseline, Week 6 after non-surgical therapy)
- Evaluation of participants' swelling on the visual analogue scale (VAS) at Week 2 post-surgery(Week 2 post-surgery)
- Mean change in marginal bone level at the implant site between Week 2 after surgery and 12 months after surgery measured in intraoral radiographs(Week 2 post-surgery, 12 months post-surgery)
- Mean peri-implant clinical attachment level from Baseline to Week 6 after non-surgical therapy(Baseline, Week 6 after non-surgical therapy)
- Mean peri-implant clinical attachment level from Baseline to 12 months after surgical therapy(Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery)
- Mean peri-implant recession from Baseline to 12 months after surgical therapy(Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery)
- Evaluation of participants' bleeding tendency when applying oral hygiene on the visual analogue scale (VAS, 10cm) at 12 months post-surgery(12 months post-surgery)
- Evaluation of patients' satisfaction on the visual analogue scale (VAS) at Week 2 post-surgery(Week 2 post-surgery)
研究者
Yiorgos A. Bobetsis
Assistant Professor
National and Kapodistrian University of Athens