Minimally-Invasive Non-Surgical Therapy of Peri-Implantitis

Sponsor
St. Anne's University Hospital Brno, Czech Republic
Study ID
NCT07466966
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Non-Surgical Peri-implant Therapy (NSPT) — PROCEDURE
    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.
  • Minimally-Invasive Non-Surgical Therapy (MINST) — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
106 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Standard Non-Surgical Peri-implant Therapy (NSPT)
    * Ultrasonic debridement with stainless steel tips * Steel curettes (Columbia 4R/4L) * Submucosal curettage * Local anesthesia
  • Experimental: 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

Primary Outcome Measure

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

Central Contacts

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