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Peri-implantitisMINST vs NSPTNCT07466966

Minimally-Invasive Non-Surgical Therapy of Peri-Implantitis

A study testing Non-Surgical Peri-implant Therapy (NSPT) and Minimally-Invasive Non-Surgical Therapy (MINST) in people with Peri-implantitis and Periodontitis, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Non-Surgical Peri-implant Therapy (NSPT) and Minimally-Invasive Non-Surgical Therapy (MINST)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteCzechia
Study dates
1 Jan 2026to Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18
  • Peri-implantitis diagnosis (PPD >6 mm, BOP+, bone loss ≥3 mm)
  • Accessible implant surface without removing suprastructure
  • FMPS <30%, FMBS <30-35%

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

MDDr. Filip Hromčík, Ph.D., MDDr., Ph.D. contact

+420 607987134

filiphromcik@mail.muni.cz

Czechia1 site, 1 recruiting

  • Syndenta s.r.o., Hlinky 92, 603 00 Brno, Czech Republic

    Brno, 60300

    MDDr. Filip Hromčík, Ph.D., MDDr., Ph.D., +420 607987134, filiphromcik@mail.muni.cz

    Petr Kořínek, MUDr., +420 773 646 646, petr@syndenta.cz

    Recruiting

Other trials in Czechia

About this study

Official title: 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.

Read the 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.

Being tested
Non-Surgical Peri-implant Therapy (NSPT), Minimally-Invasive Non-Surgical Therapy (MINST)
Keywords
peri-implantitis, MINST, non-surgical therapy, ultrasonic debridement, implant dentistry, randomised controlled trial
Medical subject headings
Peri-Implantitis, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-Surgical Peri-implant Therapy (NSPT)Procedure or surgery

    Also called 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 Non-Surgical Therapy (MINST)Procedure or surgery

    Also called 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.

Study groups in NCT07466966
Study groupRoleWhat they receive
Standard Non-Surgical Peri-implant Therapy (NSPT)Experimental* Ultrasonic debridement with stainless steel tips * Steel curettes (Columbia 4R/4L) * Submucosal curettage * Local anesthesia
Receives: Procedure: Non-Surgical Peri-implant Therapy (NSPT)
Minimally-Invasive Non-Surgical Therapy (MINST)Experimental* 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
Receives: Procedure: Minimally-Invasive Non-Surgical Therapy (MINST)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pocket closure at test site (implant site) - defined as PPD ≤5 mm, ≤1 bleeding point, no suppuration

    • 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

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months.

Secondary outcomes (11)

  1. Change in Probing Pocket Depth (PPD)

    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

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months

  2. Change in Clinical Attachment Level (CAL)

    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

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months.

  3. Radiographic Bone Level Changes

    Change in peri-implant marginal bone levels assessed on standardized periapical radiographs using paralleling technique.

    Scale: 0-20 mm, the bigger the better

    Measured: Baseline and 12 months

  4. Oral-Health-Related Quality of Life

    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

    Measured: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months

  5. Treatment Time

    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: measured onyl once, during the intervention

  6. Need for Additional or Rescue Therapy

    Proportion of implants requiring additional treatment such as repeated non-surgical therapy, adjunctive antibiotics, surgical intervention, or explantation.

    Scale: yes/no

    Measured: Up to 12 months.

  7. Full-Mouth pocket probing depth (PPD)

    Changes in full-mouth PPD (scale 0-20 mm, bigger is better), 6 sites per tooth/implant

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months.

  8. Number of participants with Post-operative Discomfort

    Patient-reported need for analgesics and type of pain medication used after the intervention.

    Scale: yes/no, specify medication

    Measured: 1-month follow-up

  9. Full-Mouth clinical attachment levels (CAL)

    Changes in full-mouth CAL, 6 sites per tooth/implant (scale 0-20 mm, bigger is better)

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months.

  10. Full-Mouth Plaque Score (FMPS)

    Plaque levels at 6 sites per tooth/implant (1 for presence / 0 for absence, absence is better)

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months.

  11. Full-Mouth Bleeding Score (FMBS)

    Changes in full-mouth bleeding score: bleeding on probing at 6 sites per tooth/implant (1 for presence / 0 for absence, absence is better).

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2026
  2. Study start1 Jan 2026
  3. Primary completionJan 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07466966
Sponsor's protocol ID
22KS/2025
Acronym
MINST vs NSPT
Status last verified
Mar 2026
First submitted
3 Mar 2026
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

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.

    PubMed 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.

    PubMed 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.

    PubMed 26257238

  • Ower P. Minimally-invasive non-surgical periodontal therapy. Dent Update. 2013 May;40(4):289-90, 293-5. doi: 10.12968/denu.2013.40.4.289.

    PubMed 23829010

  • Ribeiro FV, et al. Minimally invasive periodontal therapy: clinical outcomes and patient-centered measures. Journal of Periodontology. 2011

  • Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.

    PubMed 29926491

  • Renvert S, Polyzois I, Claffey N. How do implant surface characteristics influence peri-implant disease? J Clin Periodontol. 2011 Mar;38 Suppl 11:214-22. doi: 10.1111/j.1600-051X.2010.01661.x.

    PubMed 21323717

Questions about this trial

What is this clinical trial studying?

A study testing Non-Surgical Peri-implant Therapy (NSPT) and Minimally-Invasive Non-Surgical Therapy (MINST) in people with Peri-implantitis and Periodontitis, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact MDDr. Filip Hromčík, Ph.D., MDDr., Ph.D. (+420 607987134, filiphromcik@mail.muni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07466966, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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