Supportive Peri-implant Care Frequency After Surgical Treatment of Peri-implantitis - a Multi-center Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 152
- 主要终点
- Treatment success - criterion 1 (yes/no)
研究概览
简要总结
The leading hypothesis behind this study is that a 3-month frequency of supportive peri-implant care (SPIC) recalls after surgical therapy of implants affected by severe peri-implantitis yields better results when compared to a 6-month frequency. Thus, the primary aim of this randomized clinical trial is to compare 2 different frequencies of SPIC recalls (3 and 6 months) after surgical treatment of severe peri-implantitis in terms of treatment success (absence of implant loss, probing pocket depth (PPD) ≤ 5 mm at all aspects, bleeding on deep probing ≤1 site/implant, no suppuration at all aspects, bone loss <0.5 mm) at early follow-up (1-year) and implant survival at the 5-year examination. Secondarily, this randomized clinical trial aims to assess the effects of the 2 different frequencies over clinical attachment levels around remaining teeth.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient aged 18 years or more, who has at least one implant affected by severe peri-implantitis, and able to sign an informed consent form will be potentially eligible for this trial. Severe peri-implantitis will be defined as the presence of a peri-implant probing pocket depth [PPD] ≥ 6 mm in at least 1 site of the implant, bleeding and/or suppuration on deep probing [dBoP and/or dSoP, respectively] and radiographically documented marginal bone loss > 3 mm (Carcuac et al. 2016; Romandini et al. 2022) on implants in function by at least 12-months. In the absence of baseline radiographs, implants had to present a bone level >3 mm (Romandini et al. 2021b).
- •Patients fulfilling the above-mentioned inclusion criteria will not be included in the study if they appear to be unable to attend the study-related procedures (including the long-term follow-up visits) or if one or more of the following systemic or local
排除标准
- •are detected during the enrolment phase.
- •Systemic primary exclusion criteria:
- •systemic diseases (e.g. uncontrolled diabetes mellitus) or chronic use of medications (e.g. corticosteroids, bisphosphonates) likely to influence the outcome of therapy or which contraindicates the study procedures;
- •smoking >10 cigarettes;
- •pregnant or nursing women.
- •Local primary exclusion criteria:
- •history of peri-implantitis treatment on the eligible implants in the previous 6 months;
- •hopeless implants (>80% of bone loss/level).
- •A secondary inclusion criterion will be applied 1-month after surgery:
- •absence of peri-implant abscess on the implants to be included.
结局指标
主要结局
Treatment success - criterion 1 (yes/no)
时间窗: 1 year
Absence of implant loss, probing pocket depth ≤ 5 mm at all aspects, deep bleeding/suppuration on probing ≤1 site/implant, bone loss \<0.5 mm
Implant loss (yes/no)
时间窗: 5 years
Implant removed, or mobile, or radiographic evidence of complete loss of osseointegration.
次要结局
- Implant loss (yes/no)(1 and 3 years)
- Treatment success - criterion 1(3 and 5 years)
- Treatment success - criterion 2 (yes/no)(1, 3, and 5 years)
- Plaque presence (yes/no)(1, 3 and 5 years)
- Plaque extent(1, 3 and 5 years)
- Probing pocket depth (mm)(1, 3 and 5 years)
- Bleeding on deep probing (yes/no)(1, 3 and 5 years)
- Soft-tissue level margin (mm)(1, 3 and 5 years)
- Keratinised mucosa height (mm)(1, 3 and 5 years)
- Bleeding on superficial probing(1, 3 and 5 years)
- Suppuration (yes/no)(1, 3 and 5 years)
- Modified Bleeding Index(1, 3 and 5 years)
- Radiographic outcomes(1, 3 and 5 years)
- Patient- and clinician- esthetic appreciation(Assessed at 1, 3 and 5 years)
- Total SPIC duration (months)(Assessed at 1, 3 and 5 years)
- Number of sub-marginal re-instrumentations at study implants(Assessed at 1, 3 and 5 years)
- Compliance to SPIC regimen (yes/no)(Assessed at 1, 3 and 5 years)
- Number of surgical retreatments(Assessed at 1, 3 and 5 years)
- Rate of adverse events(Assessed at 1, 3 and 5 years)
- Full-mouth plaque score (0-100)(1, 3, and 5 years)
- Full-mouth bleeding score (0-100)(1, 3, and 5 years)
- Clinical attachment level around remaining teeth(1, 3, and 5 years)
- Chairside aMMP-8 assay (positive/negative)(1, 3, and 5 years)
- Molecular analysis in the peri-implant crevicular fluid(1 month, 6 months, 1, 3 and 5 years)
- Microbiological analysis(1 month, 6 months, 1, 3, and 5 years)
研究者
Giacomo Baima
Co-Principal Investigator (together with Mario Romandini)
University of Turin, Italy