Long-term Stability of Peri-implantitis Treatments: a 3-year Clinical Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- ecurrence/progression of peri-implantitis
研究概览
简要总结
This prospective study will include patients previously enrolled in the PER-ECL-2019-05 trial who attend the Department of Periodontology (CUO) for maintenance therapy or treatment of periodontal and/or peri-implant diseases, provided they meet the inclusion criteria.
Initially, 36 patients with advanced peri-implantitis were enrolled in a randomized clinical trial evaluating the clinical, radiographic and patient-related outcomes of reconstructive therapy following a non-surgical phase of peri-implantitis treatment compared to non-surgical treatment alone (PER-ECL-2019-05) (10).
At the study conclusion 34 patients were re-evaluated and 2 patients were excluded from the study (10).
In the original study, adult patients presenting at least one titanium implant diagnosed with peri-implantitis were identified among patients referred to the Department of Periodontology of UIC between January 2020 and October 2022. Peri-implantitis was diagnosed following the case definition of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (11) that is, PPD ≥ 6 mm combined with bleeding on probing (BOP) and/or suppuration (SUP), together with progressive bone loss in relation to the radiographic bone level assessment. In those cases where initial radiograph was unavailable, the definition of a peri-implantitis case was based on radiographic evidence of bone level ≥3 mm apical to the most coronal portion of the intra-osseous part of the implant (12).
At the outset of the original study, participants were randomly assigned to one of two groups:
The first group received only non-surgical therapy for peri-implantitis, while the second group underwent a non-surgical phase followed by reconstructive surgical treatment. This design allowed for direct comparison of the clinical, radiographic, and patient-centered outcomes between the two treatment modalities. Both groups were managed and evaluated according to standardized protocols, ensuring consistency and reliability of the results at 12 months .
Patients who have not returned to the Department will be contacted by telephone and invited to participate through the academic office.
At 36 months, a single follow-up will be carried out including:
A detailed clinical examination. A standardized radiographic assessment.
详细描述
- Introduction:
There is a notable lack of comprehensive data regarding the long-term outcomes of surgical and non-surgical interventions for peri-implantitis. Most existing evidence stems from studies with 1 year follow-up or retrospective studies (1-5).
The factors influencing the long-term stability of surgical treatment for peri-implantitis remain poorly understood. In a 7-year follow-up, Roccuzzo et al. (2017) observed that 50% of treated implants experienced recurrence of peri-implantitis, with retreatment needs being associated with implant surface characteristics (6). Similarly, Carcuac et al. (2020) found that 44% of implants showed disease recurrence after 5 years (7). More recently, Romandini et al. (2023) reported that approximately 20% of surgically treated implants were lost over a 4-year period, with implant failure being linked to the presence of baseline suppuration and the use of modified implant surfaces (4). Other studies, however, noted lower rates of recurrence/progression ranging from 20% to 32% during 3-5 years of follow-up (8,9).
Conversely, evidence regarding the long-term outcomes of non-surgical treatment for peri-implantitis remains particularly scarce in the current literature, and to date, no studies have thoroughly investigated the factors associated with the stability of such therapeutic approaches.
As part of a randomized controlled clinical trial evaluating the potential benefits of adjunctive reconstructive therapy in the management of advanced peri-implantitis, 36 patients were enrolled and followed for one year (10 ). The results indicated that both treatment strategies were moderately effective in achieving disease resolution. However, deeper baseline probing pocket depths were negatively associated with successful outcomes. Notably, sites treated with reconstructive surgical therapy demonstrated significantly greater marginal bone level gain. Despite this, the influence of improved bone support on the long-term maintenance of peri-implant health remains unclear. The present prospective study aims to elucidate further the factors associated with the long-term stability of both non-surgical and reconstructive treatment outcomes. 2. Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patiens previously enrolled in the randomized clinical trial PER-ECL-2019-05, which included 36 patients with advanced peri-implantitis.
- •2. Completion of the original study protocol, including either reconstructive surgical therapy following a non-surgical phase or non-surgical therapy alone.
- •3.Signed informed consent for participation in the follow-up assessment.
排除标准
- •1.Did not complete the original clinical trial protocol (PER-ECL-2019-05) or withdrew before final evaluation.
- •2.Had the implant removed due to complications unrelated to peri-implantitis progression.
- •3.Have developed systemic diseases or conditions (e.g., uncontrolled diabetes, immunosuppression, malignancy) that may affect periodontal or peri-implant tissue healing or confound clinical outcomes.
- •4.Are currently undergoing antibiotic or antiresorptive therapy (e.g., bisphosphonates) that could interfere with bone metabolism.
- •5.Are pregnant or breastfeeding at the time of the follow-up visit. 6.Are unwilling or unable to attend the clinical follow-up appointment or provide informed consent.
研究组 & 干预措施
'atients previously enrolled in the PER-ECL-2019-05 trial
Initially, 36 patients with advanced peri-implantitis were enrolled in a randomized clinical trial evaluating the clinical, radiographic and patient-related outcomes of reconstructive therapy following a non-surgical phase of peri-implantitis treatment compared to non-surgical treatment alone (PER-ECL-2019-05) .At the study conclusion 34 patients were re-evaluated and 2 patients were excluded from the study
结局指标
主要结局
ecurrence/progression of peri-implantitis
时间窗: 3 years
The primary outcome was recurrence/progression of peri-implantitis between years 1 and 3, defined as any of the following events: (a) bone loss \>1.0 mm, (b) surgical retreatment, (c) implant removal/loss )
recurrence/progression of peri-implantitis
时间窗: 3 years
The primary outcome was recurrence/progression of peri-implantitis between years 1 and 3, defined as any of the following events: (a) bone loss \>1.0 mm, (b) surgical retreatment, (c) implant removal/loss )
次要结局
未报告次要终点
研究者
Ramón Pons Calabuig
dds ms
Universitat Internacional de Catalunya