Clinical and Radiographic Outcomes Following Non-surgical Mechanical Therapy of Peri-implantitis With or Without Adjunctive Diode Laser Application: A 12-month Double-blinded Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in peri-implant pocket probing depth (PPD)
研究概览
简要总结
Peri-implantitis is a pathological condition occurring in tissues around dental implants, characterized by inflammation in the peri-implant connective tissue and progressive loss of supporting bone. The goals of peri-implantitis treatment is the resolution of peri-implant soft tissue inflammation and stabilization of the bony attachment (e.g., the level of osseointegration). For this decontamination of the implant surface is mandatory. In order to increase implant surface decontamination, several adjunctive tools have been proposed and investigated both in pre-clinical and clinical studies such as the use of photodynamic therapy and lasers. So far, no data are available to clearly demonstrate the efficacy of the adjunctive use of a diode laser in the non-surgical treatment of peri-implantitis. Therefore, the aim of the present randomized controlled trial (RCT) is to investigate the adjunctive effect of the application of a diode laser to treat peri-implantitis lesions by means of a non-surgical approach. A total of 30 patients is randomly allocated to two groups. The test group receives 3 x nonsurgical mechanical treatment with diode laser application whereas the control group receives the same treatment with sham laser application. The primary outcome is the peri-implant pocket probing depth at 12 months.
详细描述
Peri-implantitis is a pathological condition occurring in tissues around dental implants, characterized by inflammation in the peri-implant connective tissue and progressive loss of supporting bone. Peri-implantitis is a disease with increasing incidence that, if left untreated, leads to implant loss. The etiological factors of peri-implant infections are similar to those involved in periodontal diseases. Consequently, the goals of peri-implantitis treatment must be the resolution of peri-implant soft tissue inflammation and stabilization of the bony attachment (e.g., the level of osseointegration). This can only be achieved under the condition that the majority of bacterial biofilms and hard deposits are eliminated on the implant surface to create a biologically acceptable surface conducive to wound healing. Decontamination of the implant surface is mandatory to resolve the inflammatory process and to establish healthy peri-implant tissues. To increase implant surface decontamination, several adjunctive tools have been proposed and investigated both in pre-clinical and clinical studies such as the use of photodynamic therapy and lasers. So far, no data are available to clearly demonstrate the efficacy of the adjunctive use of a diode laser in the non-surgical treatment of peri-implantitis. Therefore, the aim of the present randomized controlled trial (RCT) is to investigate the adjunctive effect of the application of a diode laser to treat peri-implantitis lesions by means of a non-surgical approach. A total of 30 patients is randomly allocated to two groups. The test group receives 3 x nonsurgical mechanical treatment with diode laser application whereas the control group receives the same treatment with sham laser application. The primary outcome is the mean peri-implant pocket probing depth (PPD) at 12 months. The secondary endpoints are:
- Change at deepest PPD (mm)
- Change in probing attachment level (PAL) (mm)
- Change in the % of implants with BoP / SUP
- Mean radiographic bone fill (mm) at mesial and distal sites
- Change in width of keratinized mucosa (KM) (mm)
- Change in microbial samples composition at 6 and 12 months
- Changes in patients' related outcomes measures (PROMs) by means of a Visual Analogue Scale (VAS) (range: 0-10)
- Change in peri-implant crevicular fluid (PICF) composition
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, 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
- 是
入选标准
- •systemically healthy patients enrolled in regular supportive periodontal therapy (SPT)
- •Tissue level (TL) implants with an SLA surface supporting single-unit crowns (SUCs) or fixed dental prostheses (FDPs)
- •Pocket Probing Depth (PPD) > 5 mm
- •Presence of BoP and /or SU
- •Radiographic evidence of crestal bone loss ≤ 2mm based on periapical radiographs after delivery of the final restoration
- •Cleansable cemented or screw-retained restoration
- •Presence of at least 2 mm of keratinized and attached mucosa (KM)
- •Signed informed consent
排除标准
- •Systemic diseases that could interfere with the treatment outcome (e.g. uncontrolled diabetes mellitus, chemotherapy, etc.)
- •Previous peri-implantitis treatment
- •Full-Mouth Plaque Score (FMPS) > 25%
- •Full-Mouth Bleeding Score (FMBS) > 25%
- •Cigarette smoking > 10 cig./day
- •Removable implant-supported restorations
- •Implant mobility
结局指标
主要结局
Change in peri-implant pocket probing depth (PPD)
时间窗: at 12 months
the difference between baseline PPD and PPD after 12 months
次要结局
- Change in probing attachment level (PAL) (mm)(at 12 months)
- Change in the % of implants with BoP / SUP(at 12 months)
- Changes in patients' related outcomes measures (PROMs) by means of a Visual Analogue Scale (VAS) (range: 0-10)(at 12 months)
- Change at deepest PPD (mm)(at 12 months)
- Change in microbial samples composition(at 6 and 12 months)
- Mean radiographic bone fill (mm) at mesial and distal sites(at 12 months)
- Change in width of keratinized mucosa (KM) (mm)(at 12 months)
- Change in peri-implant crevicular fluid (PICF) composition(at 12 months)