MICRO-SURG: Investigation of Subgingival Microbiome Changes Following Surgical Peri-Implantitis Therapy, Regenerative Periodontal Surgery, and Resective Periodontal Surgery Using Next-Generation Sequencing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in Subgingival Microbiome Composition After Periodontal and Peri-implant Surgery
研究概览
简要总结
This clinical study investigates how the subgingival microbiome changes after three different periodontal and peri-implant surgical procedures: (1) resective periodontal surgery, (2) regenerative periodontal surgery, and (3) peri-implantitis surgery. The aim is to characterize microbial shifts associated with these commonly used surgical treatments and to determine whether the type of surgery influences the recovery or disruption of the subgingival ecosystem. Adult patients with periodontitis or peri-implantitis will receive the procedure indicated for their condition. Subgingival plaque samples will be collected at baseline and at defined postoperative follow-up intervals. Microbiome analysis will be performed using next-generation sequencing (NGS), and microbial changes will be evaluated with the Subgingival Microbial Dysbiosis Index (SMDI). Insights from this study may help improve prevention, diagnostics, and treatment strategies for periodontal and peri-implant diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Confirmed diagnosis of Peri-implantitis (for the peri-implantitis surgery arm), or Stage III/IV periodontitis (for the periodontal surgery arms)
- •Indication for surgical therapy corresponding to the assigned study arm
- •Ability to understand the study procedures and provide written informed consent
- •Adequate oral hygiene (API/SBI according to the clinician's judgment)
- •Willingness and ability to attend all follow-up visits
- •Willingness to provide salivary and subgingival plaque samples for microbiome analyses (NGS, SMDI)
排除标准
- •Systemic conditions contraindicating oral surgical procedures
- •Severe systemic diseases (e.g., uncontrolled diabetes mellitus, immunosuppressive disorders)
- •Use of systemic antibiotics within the previous 3 months
- •Active COVID-19 infection at the time of surgery
- •Pregnancy or breastfeeding
- •Drug or alcohol abuse
- •Smoking more than 10 cigarettes per day
- •Known allergies to materials used in the assigned intervention (e.g., local anesthetics, sutures, membranes, bone grafting materials)
- •Participation in another clinical study within the previous 30 days
- •Acute oral infections that contraindicate participation
- •Inability or unwillingness to comply with all follow-up appointments Lack of capacity to provide informed consent
研究组 & 干预措施
Resective Periodontal Surgery
Participants in this arm undergo subgingival microbiome sampling in the context of resective periodontal surgery. Microbiome samples are collected at standardized time points (preoperative baseline, intraoperative sampling, and postoperative follow-ups). Samples are analyzed using next-generation sequencing (NGS), including 16S rRNA profiling, and Structure-Microbial Diversity Index (SMDI) evaluation. The goal is to characterize microbial shifts associated with resective periodontal therapy.
干预措施: Resective Periodontal Surgery (Procedure)
Regenerative Periodontal Surgery
Participants undergoing regenerative periodontal therapy are enrolled for longitudinal subgingival microbiome analysis. Microbiome samples are obtained at predefined time points (baseline, intraoperative, postoperative). Sequencing is performed using next-generation sequencing (NGS) and 16S rRNA analysis, with SMDI calculations to assess microbial diversity changes associated with regenerative procedures.
干预措施: Regenerative Periodontal Surgery (Procedure)
Peri-Implantitis Surgery
Participants in this arm receive systematic peri-implant microbiome profiling before, during, and after peri-implantitis surgery. Sampling includes submucosal/peri-implant biofilm collection at standardized visits. Analyses include next-generation sequencing (NGS), 16S rRNA sequencing, and SMDI-based microbial diversity assessment to evaluate microbial changes associated with peri-implantitis therapy.
干预措施: Surgical Peri-implantitis Therapy (Procedure)
结局指标
主要结局
Change in Subgingival Microbiome Composition After Periodontal and Peri-implant Surgery
时间窗: Baseline (preoperative), intraoperative sampling (Day 0), 1 week, 4 weeks, and 12 weeks postoperatively
Assessment of changes in the subgingival and peri-implant microbiome before, during, and after surgical treatment. Microbiome samples are collected at standardized time points and analyzed using next-generation sequencing (NGS), including 16S rRNA gene sequencing and Structure Microbial Diversity Index (SMDI). The primary outcome reflects quantitative and qualitative microbial shifts induced by resective periodontal surgery, regenerative periodontal surgery, or peri-implantitis surgery.
次要结局
- Clinical attachment level (CAL) change(Baseline and 12 weeks postoperatively)
- Probing depth (PD) change(Baseline (preoperative) and 12 weeks postoperatively)
- Implant pocket change(Baseline (preoperative) and 12 weeks postoperatively)
- Clinical attachment level (CAL) gain(Baseline and 12 weeks postoperatively)
- Probing depth (PD) reduction(Baseline (preoperative) and 12 weeks postoperatively)
- Bleeding on probing(Baseline (preoperative) and 12 weeks postoperatively)
- Implant pocket reduction(Baseline (preoperative) and 12 weeks postoperatively)