Minimally-Invasive Non-Surgical Therapy of Peri-Implantitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Anne's University Hospital Brno, Czech Republic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18
Peri-implantitis diagnosis (PPD >6 mm, BOP+, bone loss ≥3 mm)
Accessible implant surface without removing suprastructure
FMPS <30%, FMBS <30-35%
Disqualifiers
Antibiotics in last 3 months
Pregnancy/lactation
Uncontrolled diabetes (HbA1c ≥7)
Long-term SPIC (>2 years)
Trial design
Design model
Parallel
Treatments tested in this trial
Non-Surgical Peri-implant Therapy (NSPT)
Procedure/SurgeryStandard 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/SurgeryMinimally 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.
Treatment groups
106 Participants
are divided into 2 treatment groupsGroup A: Standard Non-Surgical Peri-implant Therapy (NSPT)Experimental treatment 1 intervention
Group B: Minimally-Invasive Non-Surgical Therapy (MINST)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pocket 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.Secondary outcomes
1
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 months2
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.3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Anne's University Hospital Brno, Czech Republic
Lead sponsor
King's College London
Collaborator
Source ClinicalTrials.gov