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RecruitingNCT07466966

Minimally-Invasive Non-Surgical Therapy of Peri-Implantitis

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
106 (estimated)
Sponsor
St. Anne's University Hospital Brno, Czech Republic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDURENon-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.
PROCEDUREMinimally-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.

Timeline

Start date
2026-01-01
Primary completion
2028-01-01
Completion
2028-04-01
First posted
2026-03-12
Last updated
2026-03-13

Locations

1 site across 1 country: Czechia

Source: ClinicalTrials.gov record NCT07466966. Inclusion in this directory is not an endorsement.