Minimally-Invasive Non-Surgical Therapy of Peri-Implantitis (MINST vs NSPT)

March 11, 2026 updated by: Filip Hromcik, St. Anne's University Hospital Brno, Czech Republic

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Brno, Czechia, 60300
        • Recruiting
        • Syndenta s.r.o., Hlinky 92, 603 00 Brno, Czech Republic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Filip Hromčík, MDDr., Ph.D.
        • Sub-Investigator:
          • Veronika Chuchmová, Mgr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard Non-Surgical Peri-implant Therapy (NSPT)
  • Ultrasonic debridement with stainless steel tips
  • Steel curettes (Columbia 4R/4L)
  • Submucosal curettage
  • Local anesthesia
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.
Other Names:
  • NSPT
Experimental: Minimally-Invasive Non-Surgical Therapy (MINST)
  • Exclusive use of thin, non-diamond ultrasonic tips (PS, PL1, PL2, Siroperio, Woodpecker P3, Acteon 10Z)
  • ≥3× magnification
  • Aim to obtain stable blood clot formation
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.
Other Names:
  • MINST

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
  • 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
Baseline, 3 months, 6 months, 9 months, 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Probing Pocket Depth (PPD)
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
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.

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
Baseline, 3 months, 6 months, 9 months, 12 months.
Radiographic Bone Level Changes
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
Baseline and 12 months
Treatment Time
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
measured onyl once, during the intervention
Need for Additional or Rescue Therapy
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
Up to 12 months.
Full-Mouth pocket probing depth (PPD)
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
Baseline, 3 months, 6 months, 9 months, 12 months.
Number of participants with Post-operative Discomfort
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
1-month follow-up
Full-Mouth clinical attachment levels (CAL)
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)
Baseline, 3 months, 6 months, 9 months, 12 months.
Oral-Health-Related Quality of Life
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
Baseline, 1 month, 3 months, 6 months, 9 months, 12 months
Full-Mouth Plaque Score (FMPS)
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)
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.
Changes in full-mouth bleeding score: bleeding on probing at 6 sites per tooth/implant (1 for presence / 0 for absence, absence is better).
Baseline, 3 months, 6 months, 9 months, 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Anne's University Hospital Brno, Czech Republic

Collaborators

King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 8, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22KS/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The following pseudonymized datasets will be shared:

  • Clinical measurements (PPD, CAL, BOP, plaque scores, keratinized tissue parameters)
  • Radiographic bone level measurements
  • PROMs (OHIP-14 responses)
  • Microbiological plaque analysis results
  • Treatment-related variables (treatment allocation, treatment time, need for rescue therapy)
  • Demographic and baseline characteristics (age, sex, smoking status, BMI, education level)

Identifiable personal data (name, date of birth, contact details, full medical record) will not be shared

IPD Sharing Time Frame

After completion of primary analyses, expected April 2028

IPD Sharing Access Criteria

Pseudonymized data from the Brno study site will be shared with the coordinating research institution:

King's College London, Faculty of Dentistry, Centre for Host-Microbiome Interactions.

Data may also be shared with authorized members of the multicenter research team and regulatory bodies involved in oversight.

Access will be restricted to authorized study personnel under data-sharing agreements compliant with GDPR and UK data protection regulations.

IPD Sharing Supporting Information Type

  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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