NCT Number: NCT07466966
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Brno, 60300, Czechia
Location status: Recruiting
Filip Hromčík, MDDr., Ph.D.
PRINCIPAL_INVESTIGATOR
MDDr. Filip Hromčík, Ph.D., MDDr., Ph.D.
CONTACT
Petr Kořínek, MUDr.
CONTACT
Veronika Chuchmová, Mgr.
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: NSPT
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.
Other names: MINST
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months.
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
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 (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 and 12 months
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, 1 month, 3 months, 6 months, 9 months, 12 months
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: measured onyl once, during the intervention
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: Up to 12 months.
Proportion of implants requiring additional treatment such as repeated non-surgical therapy, adjunctive antibiotics, surgical intervention, or explantation.
Scale: yes/no
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months.
Changes in full-mouth PPD (scale 0-20 mm, bigger is better), 6 sites per tooth/implant
Time frame: 1-month follow-up
Patient-reported need for analgesics and type of pain medication used after the intervention.
Scale: yes/no, specify medication
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months.
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.
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.
Changes in full-mouth bleeding score: bleeding on probing at 6 sites per tooth/implant (1 for presence / 0 for absence, absence is better).
Contact information is provided by the study sponsor or research team.
St. Anne's University Hospital Brno, Czech Republic
Other
Minimally-Invasive Non-Surgical Therapy of Peri-Implantitis: A Multicenter Randomized Controlled Trial (MINST vs NSPT)
Acronym: MINST vs NSPT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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