Minimally-Invasive Non-Surgical Therapy of Peri-Implantitis

Официальное название

Minimally-Invasive Non-Surgical Therapy of Peri-Implantitis: A Multicenter Randomized Controlled Trial (MINST vs NSPT)

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Non-Surgical Peri-implant Therapy (NSPT)
  Standard mechanical debridement of the peri-implant pocket performed under local anesthesia. Treatment includes supra- and submucosal ultrasonic debridement using stainless-steel ultrasonic tips, followed by mechanical curettage of granulation tissue with steel curettes (Columbia 4R/4L). Soft-tissue curettage is performed from the inner aspect of the peri-implant pocket. No time restriction is imposed; the operator works until the implant surface is clinically clean.
• Процедура Minimally-Invasive Non-Surgical Therapy (MINST)
  Minimally invasive ultrasonic debridement performed under local anesthesia using exclusively thin, non-diamond ultrasonic tips (Satalec PS3, EMS PS, PS, PL1, PL2; Siroperio 1/2/3/7; Woodpecker P3; Acteon 10Z). Treatment is carried out under ≥3× magnification with emphasis on tissue preservation. The operator aims to achieve a stable blood clot emerging from the peri-implant pocket after instrumentation. No curettes or sharp instruments are used.

Первичные конечные точки

• Pocket closure at test site (implant site) - defined as PPD ≤5 mm, ≤1 bleeding point, no suppuration [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months.]

Вторичные конечные точки (11)

• Change in Probing Pocket Depth (PPD) [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months]
• Change in Clinical Attachment Level (CAL) [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months.]
• Radiographic Bone Level Changes [Срок оценки: Baseline and 12 months]
• Oral-Health-Related Quality of Life [Срок оценки: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months]
• Treatment Time [Срок оценки: measured onyl once, during the intervention]
• Need for Additional or Rescue Therapy [Срок оценки: Up to 12 months.]
• Full-Mouth pocket probing depth (PPD) [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months.]
• Number of participants with Post-operative Discomfort [Срок оценки: 1-month follow-up]
• Full-Mouth clinical attachment levels (CAL) [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months.]
• Full-Mouth Plaque Score (FMPS) [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months.]
• Full-Mouth Bleeding Score (FMBS) [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months.]

Критерии участия

Критерии включения

• Age ≥18
• Peri-implantitis diagnosis (PPD >6 mm, BOP+, bone loss ≥3 mm)
• Accessible implant surface without removing suprastructure
• FMPS <30%, FMBS <30-35%

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Чехия · 1 центр

• Syndenta s.r.o., Hlinky 92, 603 00 Brno, Czech Republic — Brno

Публикации

• Herrera D, et al. Management of peri-implant diseases: clinical guidelines. Journal of Clinical Periodontology. 2023
• European Federation of Periodontology (EFP). Guidelines for the treatment of peri-implant diseases. Periodontology 2000. 2019.
• Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x. PMID 9332805
• Guerrero A, et al. Intra- and inter-examiner reproducibility of periodontal measurements. Journal of Clinical Periodontology. 2005.
• Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz RI. Stratified randomization for clinical trials. J Clin Epidemiol. 1999 Jan;52(1):19-26. doi: 10.1016/s0895-4356(98)00138-3. PMID 9973070
• Blanco J, et al. Non-surgical treatment of peri-implantitis: randomized clinical trial. Journal of Clinical Periodontology. 2022.
• Liñares A, et al. Non-surgical therapy of peri-implantitis: clinical outcomes of ultrasonic debridement. Journal of Clinical Periodontology. 2019.
• Nibali L, Pometti D, Chen TT, Tu YK. Minimally invasive non-surgical approach for the treatment of periodontal intrabony defects: a retrospective analysis. J Clin Periodontol. 2015 Sep;42(9):853-859. doi: 10.1111/jcpe.12443. Epub 2015 Sep 29. PMID 26257238

Идентификаторы

NCT: NCT07466966 · 22KS/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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