NCT07466966

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Jan 2026Apr 2028

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 3, 2026

Last Update Submit

March 11, 2026

Conditions

Peri-implantitisPeriodontitisNon-surgical Periodontal Therapy

Keywords

peri-implantitisMINSTnon-surgical therapyultrasonic debridementimplant dentistryrandomised controlled trial

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (11)

  • Change in Probing Pocket Depth (PPD)

    Baseline, 3 months, 6 months, 9 months, 12 months

  • Change in Clinical Attachment Level (CAL)

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

  • Radiographic Bone Level Changes

    Baseline and 12 months

  • Oral-Health-Related Quality of Life

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

  • Treatment Time

    measured onyl once, during the intervention

  • +6 more secondary outcomes

Study Arms (2)

Standard Non-Surgical Peri-implant Therapy (NSPT)

EXPERIMENTAL

* Ultrasonic debridement with stainless steel tips * Steel curettes (Columbia 4R/4L) * Submucosal curettage * Local anesthesia

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

Procedure: Minimally-Invasive Non-Surgical Therapy (MINST)

Interventions

Non-Surgical Peri-implant Therapy (NSPT)PROCEDURE

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.

Also known as: NSPT
Standard Non-Surgical Peri-implant Therapy (NSPT)
Minimally-Invasive Non-Surgical Therapy (MINST)PROCEDURE

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.

Also known as: MINST
Minimally-Invasive Non-Surgical Therapy (MINST)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Brno, 60300, Czechia

RECRUITING

Related Publications (13)

  • Herrera D, et al. Management of peri-implant diseases: clinical guidelines. Journal of Clinical Periodontology. 2023

    BACKGROUND

  • European Federation of Periodontology (EFP). Guidelines for the treatment of peri-implant diseases. Periodontology 2000. 2019.

    BACKGROUND

  • Slade GD. Derivation and validation of a short-form oral health impact profile (OHIP-14). Community Dentistry and Oral Epidemiology. 1997.

    BACKGROUND

  • Guerrero A, et al. Intra- and inter-examiner reproducibility of periodontal measurements. Journal of Clinical Periodontology. 2005.

    BACKGROUND

  • Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz RI. Stratified randomization for clinical trials. Journal of Clinical Epidemiology. 1999.

    BACKGROUND

  • Blanco J, et al. Non-surgical treatment of peri-implantitis: randomized clinical trial. Journal of Clinical Periodontology. 2022.

    BACKGROUND

  • Liñares A, et al. Non-surgical therapy of peri-implantitis: clinical outcomes of ultrasonic debridement. Journal of Clinical Periodontology. 2019.

    BACKGROUND

  • Nibali L, et al. Minimally invasive non-surgical approach for periodontal intrabony defects: clinical and radiographic outcomes. Journal of Clinical Periodontology. 2015

    BACKGROUND

  • Ower P. Minimally invasive non-surgical periodontal therapy. Dental Update. 2013

    BACKGROUND

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

    BACKGROUND

  • Berglundh T, Armitage G, Araujo MG, et al. (2018) Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop. PMID: 29926491

    BACKGROUND

  • Renvert S, Polyzois I, Claffey N. (2018) How do implant surface characteristics influence peri-implant disease? PMID: 29405317

    BACKGROUND

  • 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.

    PMID: 29926491BACKGROUND

MeSH Terms

Conditions

Peri-ImplantitisPeriodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

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

CONTACT

+420 607987134filiphromcik@mail.muni.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 12, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
SAP, CSR
Time Frame
After completion of primary analyses, expected April 2028
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.

Locations

CZ(1)