Non-surgical Periodontal Therapy, Peri-implantitis, Periodontitis
Conditions
Keywords
peri-implantitis, MINST, non-surgical therapy, ultrasonic debridement, implant dentistry, randomised controlled trial
Brief summary
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.
Detailed 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.
Interventions
PROCEDURENon-Surgical Peri-implant Therapy (NSPT)
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.
Sponsors
St. Anne's University Hospital Brno, Czech Republic
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be masked to treatment allocation. The clinician performing the intervention and the patient cannot be masked due to the nature of the procedures. The examiner responsible for clinical measurements will not have access to treatment records or allocation information. The statistician analyzing the data will also remain masked until the database is locked.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pocket closure at test site (implant site) - defined as PPD ≤5 mm, ≤1 bleeding point, no suppuration | Baseline, 3 months, 6 months, 9 months, 12 months. | * 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing Pocket Depth (PPD) | 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 |
| Change in Clinical Attachment Level (CAL) | 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 |
| Radiographic Bone Level Changes | 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 |
| Oral-Health-Related Quality of Life | 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 |
| Treatment Time | 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 |
| Need for Additional or Rescue Therapy | 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 |
| Full-Mouth pocket probing depth (PPD) | 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 |
| Number of participants with Post-operative Discomfort | 1-month follow-up | Patient-reported need for analgesics and type of pain medication used after the intervention. Scale: yes/no, specify medication |
| Full-Mouth clinical attachment levels (CAL) | 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) |
| Full-Mouth Plaque Score (FMPS) | 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) |
| Full-Mouth Bleeding Score (FMBS) | 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). |
Countries
Czechia
Contacts
CONTACTMDDr. Filip Hromčík, Ph.D., MDDr., Ph.D.
Outcome results
None listed