Overview
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.
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.
Eligibility
Inclusion Criteria:
- Age ≥18
- Peri-implantitis diagnosis (PPD \>6 mm, BOP+, bone loss ≥3 mm)
- Accessible implant surface without removing suprastructure
- FMPS \<30%, FMBS \<30-35%
Exclusion Criteria:
- Antibiotics in last 3 months
- Pregnancy/lactation
- Uncontrolled diabetes (HbA1c ≥7)
- Long-term SPIC (\>2 years)
- Previous implant therapy \<12 months
- Smoking/vaping in last 12 months
- Hopeless implant
- Need for adjunctive antibiotics
