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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
106
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 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.
Syndenta s.r.o., Hlinky 92, 603 00 Brno, Czech Republic
Brno, Czechia
RECRUITINGPocket closure at test site (implant site) - defined as PPD ≤5 mm, ≤1 bleeding point, no suppuration
* 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
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months.
Change in Probing Pocket Depth (PPD)
Mean change in probing pocket depth (mm) at the study implant (test site), measured at six sites per implant using a UNC-15 periodontal probe. Scale: 0-20 mm, the bigger the better
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in Clinical Attachment Level (CAL)
Change in clinical attachment level (mm) at the study implant (test site), calculated as PPD + gingival recession at six sites per implant. Scale: 0-20 mm, the bigger the better
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months.
Radiographic Bone Level Changes
Change in peri-implant marginal bone levels assessed on standardized periapical radiographs using paralleling technique. Scale: 0-20 mm, the bigger the better
Time frame: Baseline and 12 months
Oral-Health-Related Quality of Life
Change in patient-reported oral-health-related quality of life measured using the OHIP-14 questionnaire. 14 questions with answers: yes/no/I don't know, none is considered better than others
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months
Treatment Time
Total duration (minutes) of the intervention visit (Visit 2), recorded from start to completion of instrumentation. Scale: 0-60 minutes, no outcome superior to other
Time frame: measured onyl once, during the intervention
Need for Additional or Rescue Therapy
Proportion of implants requiring additional treatment such as repeated non-surgical therapy, adjunctive antibiotics, surgical intervention, or explantation. Scale: yes/no
Time frame: Up to 12 months.
Full-Mouth pocket probing depth (PPD)
Changes in full-mouth PPD (scale 0-20 mm, bigger is better), 6 sites per tooth/implant
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months.
Number of participants with Post-operative Discomfort
Patient-reported need for analgesics and type of pain medication used after the intervention. Scale: yes/no, specify medication
Time frame: 1-month follow-up
Full-Mouth clinical attachment levels (CAL)
Changes in full-mouth CAL, 6 sites per tooth/implant (scale 0-20 mm, bigger is better)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months.
Full-Mouth Plaque Score (FMPS)
Plaque levels at 6 sites per tooth/implant (1 for presence / 0 for absence, absence is better)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months.
Full-Mouth Bleeding Score (FMBS)
Changes in full-mouth bleeding score: bleeding on probing at 6 sites per tooth/implant (1 for presence / 0 for absence, absence is better).
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months.
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