Comparison of Trehalose and Glycine Air-Polishing Powders in the Supportive Treatment of Peri-Implant Mucositis and Their Effect on Implant Surface Integrity: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in plaque accumulation assessed by Plaque Index (PI)
研究概览
简要总结
This randomized controlled clinical trial investigates the effectiveness of trehalose powder compared to glycine powder when used in air-polishing during supportive therapy for peri-implant mucositis, a reversible inflammatory condition affecting the soft tissues around dental implants.
A total of 40 adult patients with peri-implant mucositis will be enrolled and randomly assigned to receive non-surgical periodontal therapy combined with air-polishing using either trehalose powder (test group) or glycine powder (control group). Clinical parameters will be evaluated at baseline, 1 month, 3 months, and 6 months. These include Plaque Index (PI), Bleeding on Probing (BoP), Probing Pocket Depth (PPD), and Bleeding Score (BS), in order to assess plaque accumulation, inflammation, and bleeding.
The primary objective is to compare the reduction in plaque levels between the two groups over the study period. Secondary outcomes include evaluation of changes in gingival inflammation and probing depths, as well as assessment of implant surface integrity through in vitro scanning electron microscopy (SEM) after treatment.
The aim of the study is to determine whether trehalose powder offers improved clinical outcomes and greater implant surface preservation compared to glycine powder in the non-surgical management of peri-implant mucositis.
详细描述
Peri-implant mucositis is a reversible inflammatory condition affecting the soft tissues surrounding dental implants and represents an early stage in the progression toward peri-implantitis if left untreated. Mechanical debridement combined with minimally invasive biofilm removal strategies has become the cornerstone of current supportive therapy. Among the available options, air-polishing powders have shown favorable outcomes in biofilm disruption without damaging implant surfaces or peri-implant tissues.
This randomized controlled clinical trial aims to compare the clinical efficacy and safety of trehalose powder versus glycine powder in supportive treatment of peri-implant mucositis. Trehalose is a disaccharide with documented antioxidant, anti-inflammatory, and cytoprotective properties, potentially enhancing tissue healing. Glycine, an amino acid widely used in air-polishing, has proven effective in biofilm removal with high biocompatibility and minimal abrasiveness.
Forty patients diagnosed with peri-implant mucositis will be randomly assigned to two groups: a test group receiving supportive periodontal therapy plus air-polishing with trehalose powder, and a control group receiving the same protocol with glycine powder. Clinical outcomes, including plaque accumulation, bleeding on probing, probing pocket depth, and bleeding score, will be assessed at baseline and at 1, 3, and 6 months. In addition, in vitro scanning electron microscopy (SEM) will evaluate implant surface integrity after treatment.
The study is designed to provide new clinical and morphological evidence on the potential benefits of trehalose in peri-implant maintenance protocols and to clarify whether it may represent a valid alternative to glycine for long-term implant health.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 18 and 70 years
- •Presence of peri-implant mucositis, defined as bleeding on probing (BoP) around implants without radiographic evidence of bone loss beyond initial remodeling
- •Visible biofilm on implant surfaces
- •Ability to understand and sign informed consent
- •Good oral hygiene and patient compliance
- •Availability for all follow-up visits (1, 3, and 6 months)
排除标准
- •Presence of systemic conditions that may affect healing (e.g., uncontrolled diabetes, immunosuppression)
- •Current smokers or former smokers who quit less than 6 months ago
- •Pregnant or breastfeeding women
- •Use of antibiotics or anti-inflammatory drugs in the 3 months prior to baseline
- •Presence of peri-implantitis (i.e., bleeding on probing with concomitant radiographic bone loss)
- •History of head and neck radiotherapy
- •Presence of pacemakers or cardiac stimulators
- •Neurological or psychological disorders affecting study compliance
研究组 & 干预措施
Trehalose Powder Air-Polishing with Supportive Peri-Implant Therapy
Patients receive supragingival and subgingival air-polishing with trehalose powder in combination with supportive peri-implant therapy, including manual and ultrasonic debridement, at baseline, 1, 3, and 6 months. Clinical parameters evaluated include Plaque Index (PI), Bleeding on Probing (BoP), Probing Pocket Depth (PPD), and Bleeding Score (BS). In vitro scanning electron microscopy (SEM) is used to assess potential alterations on the implant surface.
干预措施: Trehalose Powder Air-Polishing (Device)
Glycine Powder Air-Polishing with Supportive Peri-Implant Therapy
Patients receive supragingival and subgingival air-polishing with glycine powder in combination with supportive peri-implant therapy, including manual and ultrasonic debridement, at the same timepoints (baseline, 1, 3, and 6 months). The same clinical parameters (PI, BoP, PPD, BS) are recorded. Implant surface integrity is assessed post-treatment by scanning electron microscopy (SEM).
干预措施: Glycine Powder Air-Polishing (Device)
结局指标
主要结局
Change in plaque accumulation assessed by Plaque Index (PI)
时间窗: Baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3)
The Plaque Index (PI) will be used to assess the amount of bacterial plaque on peri-implant surfaces in patients with peri-implant mucositis. The PI will be recorded on four surfaces per implant (mesial, distal, buccal, and palatal/lingual) following application of a plaque disclosing agent. Scores will be assigned according to a standardized ordinal scale: score 0 indicates no plaque; score 1 corresponds to a thin film of plaque detectable only with a disclosing agent or upon probing; score 2 indicates a moderate accumulation of soft deposits visible to the naked eye; and score 3 reflects abundant plaque deposits on the gingival margin and adjacent implant surfaces. The PI for each implant will be calculated as the mean of the four site-specific scores. The primary endpoint is the difference in mean PI scores between the trehalose and glycine groups across all timepoints. Outcome assessors will be calibrated and blinded to group allocation.
次要结局
- Change in peri-implant inflammation assessed by Bleeding on Probing (BoP)(Baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3))
- Change in peri-implant probing depth assessed by Probing Pocket Depth (PPD)(Baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3))
- Change in gingival bleeding severity assessed by Bleeding Score (BS)(Baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3))
- Changes in implant surface morphology assessed by Scanning Electron Microscopy (SEM)(6 months (T3))
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia