Minimally-Invasive Non-Surgical Therapy of Peri-Implantitis: A Multicenter Randomized Controlled Trial (MINST vs NSPT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Pocket closure at test site (implant site) - defined as PPD ≤5 mm, ≤1 bleeding point, no suppuration
研究概览
简要总结
This multicenter, single-masked randomized controlled clinical trial evaluates the effectiveness of minimally-invasive non-surgical therapy (MINST) compared with standard non-surgical peri-implant therapy (NSPT) in patients diagnosed with peri-implantitis. The study investigates clinical outcomes, radiographic bone levels, patient-reported outcomes, and treatment time over 12 months.
详细描述
Peri-implantitis is an inflammatory condition characterized by bleeding on probing, probing depths ≥6 mm, and radiographic bone loss. MINST is a refined, tissue-preserving approach using delicate ultrasonic tips under magnification, while NSPT includes ultrasonic debridement combined with steel curettes and soft-tissue curettage. Both treatments are standard of care.
The study includes 7 visits over 12 months, with clinical measurements, radiographs, plaque sampling, PROMs, and standardized instrumentation protocols.
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)
盲法说明
Outcome assessors will be masked to treatment allocation. The clinician performing the intervention and the patient cannot be masked due to the nature of the procedures.
The examiner responsible for clinical measurements will not have access to treatment records or allocation information.
The statistician analyzing the data will also remain masked until the database is locked.
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
- •Peri-implantitis diagnosis (PPD >6 mm, BOP+, bone loss ≥3 mm)
- •Accessible implant surface without removing suprastructure
- •FMPS <30%, FMBS <30-35%
排除标准
- •Antibiotics in last 3 months
- •Pregnancy/lactation
- •Uncontrolled diabetes (HbA1c ≥7)
- •Long-term SPIC (>2 years)
- •Previous implant therapy <12 months
- •Smoking/vaping in last 12 months
- •Hopeless implant
- •Need for adjunctive antibiotics
研究组 & 干预措施
Standard Non-Surgical Peri-implant Therapy (NSPT)
- Ultrasonic debridement with stainless steel tips
- Steel curettes (Columbia 4R/4L)
- Submucosal curettage
- Local anesthesia
干预措施: Non-Surgical Peri-implant Therapy (NSPT) (Procedure)
Minimally-Invasive Non-Surgical Therapy (MINST)
- Exclusive use of thin, non-diamond ultrasonic tips (PS, PL1, PL2, Siroperio, Woodpecker P3, Acteon 10Z)
- ≥3× magnification
- Aim to obtain stable blood clot formation
干预措施: Minimally-Invasive Non-Surgical Therapy (MINST) (Procedure)
结局指标
主要结局
Pocket closure at test site (implant site) - defined as PPD ≤5 mm, ≤1 bleeding point, no suppuration
时间窗: Baseline, 3 months, 6 months, 9 months, 12 months.
* PPD ≤5 mm * ≤1 bleeding point * No suppuration Scale: 0-20 mm, the smaller the better, 4 mm is considered qualifying as a pocket closure and successful therapy
次要结局
- Change in Probing Pocket Depth (PPD)(Baseline, 3 months, 6 months, 9 months, 12 months)
- Change in Clinical Attachment Level (CAL)(Baseline, 3 months, 6 months, 9 months, 12 months.)
- Radiographic Bone Level Changes(Baseline and 12 months)
- Treatment Time(measured onyl once, during the intervention)
- Need for Additional or Rescue Therapy(Up to 12 months.)
- Full-Mouth pocket probing depth (PPD)(Baseline, 3 months, 6 months, 9 months, 12 months.)
- Number of participants with Post-operative Discomfort(1-month follow-up)
- Full-Mouth clinical attachment levels (CAL)(Baseline, 3 months, 6 months, 9 months, 12 months.)
- Oral-Health-Related Quality of Life(Baseline, 1 month, 3 months, 6 months, 9 months, 12 months)
- Full-Mouth Plaque Score (FMPS)(Baseline, 3 months, 6 months, 9 months, 12 months.)
- Full-Mouth Bleeding Score (FMBS)(Baseline, 3 months, 6 months, 9 months, 12 months.)
研究者
Filip Hromcik
Principal Investigator
St. Anne's University Hospital Brno, Czech Republic