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Recruiting NCT07466966

Minimally-Invasive Non-Surgical Therapy of Peri-Implantitis

No phase Interventional Peri-implantitis Periodontitis Non-surgical Periodontal Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Surgical Peri-implant Therapy (NSPT), Minimally-Invasive Non-Surgical Therapy (MINST).
Who it may be relevant to
Registry conditions: Peri-implantitis, Periodontitis, Non-surgical Periodontal Therapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Minimally-Invasive Non-Surgical Therapy of Peri-Implantitis: A Multicenter Randomized Controlled Trial (MINST vs NSPT)

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.

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

  • Procedure Non-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.
  • Procedure Minimally-Invasive Non-Surgical Therapy (MINST)
    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.

Primary outcome measures

  • Pocket closure at test site (implant site) - defined as PPD ≤5 mm, ≤1 bleeding point, no suppuration [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months.]
Secondary outcome measures (11)
  • Change in Probing Pocket Depth (PPD) [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months]
  • Change in Clinical Attachment Level (CAL) [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months.]
  • Radiographic Bone Level Changes [Time frame: Baseline and 12 months]
  • Oral-Health-Related Quality of Life [Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months]
  • Treatment Time [Time frame: measured onyl once, during the intervention]
  • Need for Additional or Rescue Therapy [Time frame: Up to 12 months.]
  • Full-Mouth pocket probing depth (PPD) [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months.]
  • Number of participants with Post-operative Discomfort [Time frame: 1-month follow-up]
  • Full-Mouth clinical attachment levels (CAL) [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months.]
  • Full-Mouth Plaque Score (FMPS) [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months.]
  • Full-Mouth Bleeding Score (FMBS) [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Czechia · 1 center
  • Syndenta s.r.o., Hlinky 92, 603 00 Brno, Czech Republic — Brno

Publications

  • Herrera D, et al. Management of peri-implant diseases: clinical guidelines. Journal of Clinical Periodontology. 2023
  • European Federation of Periodontology (EFP). Guidelines for the treatment of peri-implant diseases. Periodontology 2000. 2019.
  • Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x. PMID 9332805
  • Guerrero A, et al. Intra- and inter-examiner reproducibility of periodontal measurements. Journal of Clinical Periodontology. 2005.
  • Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz RI. Stratified randomization for clinical trials. J Clin Epidemiol. 1999 Jan;52(1):19-26. doi: 10.1016/s0895-4356(98)00138-3. PMID 9973070
  • Blanco J, et al. Non-surgical treatment of peri-implantitis: randomized clinical trial. Journal of Clinical Periodontology. 2022.
  • Liñares A, et al. Non-surgical therapy of peri-implantitis: clinical outcomes of ultrasonic debridement. Journal of Clinical Periodontology. 2019.
  • Nibali L, Pometti D, Chen TT, Tu YK. Minimally invasive non-surgical approach for the treatment of periodontal intrabony defects: a retrospective analysis. J Clin Periodontol. 2015 Sep;42(9):853-859. doi: 10.1111/jcpe.12443. Epub 2015 Sep 29. PMID 26257238

Identifiers

NCT: NCT07466966 · 22KS/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗