Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 8:52 PM
Study NCT ID:
NCT07466966
Status:
RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimally-Invasive Non-Surgical Therapy of Peri-Implantitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '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.\n\nThe examiner responsible for clinical measurements will not have access to treatment records or allocation information.\n\nThe statistician analyzing the data will also remain masked until the database is locked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-08', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pocket closure at test site (implant site) - defined as PPD ≤5 mm, ≤1 bleeding point, no suppuration', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months.', 'description': '* PPD ≤5 mm\n* ≤1 bleeding point\n* No suppuration\n\nScale: 0-20 mm, the smaller the better, 4 mm is considered qualifying as a pocket closure and successful therapy'}], 'secondaryOutcomes': [{'measure': 'Change in Probing Pocket Depth (PPD)', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': '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.\n\nScale: 0-20 mm, the bigger the better'}, {'measure': 'Change in Clinical Attachment Level (CAL)', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months.', 'description': 'Change in clinical attachment level (mm) at the study implant (test site), calculated as PPD + gingival recession at six sites per implant.\n\nScale: 0-20 mm, the bigger the better'}, {'measure': 'Radiographic Bone Level Changes', 'timeFrame': 'Baseline and 12 months', 'description': 'Change in peri-implant marginal bone levels assessed on standardized periapical radiographs using paralleling technique.\n\nScale: 0-20 mm, the bigger the better'}, {'measure': 'Oral-Health-Related Quality of Life', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months, 9 months, 12 months', 'description': "Change in patient-reported oral-health-related quality of life measured using the OHIP-14 questionnaire.\n\n14 questions with answers: yes/no/I don't know, none is considered better than others"}, {'measure': 'Treatment Time', 'timeFrame': 'measured onyl once, during the intervention', 'description': 'Total duration (minutes) of the intervention visit (Visit 2), recorded from start to completion of instrumentation.\n\nScale: 0-60 minutes, no outcome superior to other'}, {'measure': 'Need for Additional or Rescue Therapy', 'timeFrame': 'Up to 12 months.', 'description': 'Proportion of implants requiring additional treatment such as repeated non-surgical therapy, adjunctive antibiotics, surgical intervention, or explantation.\n\nScale: yes/no'}, {'measure': 'Full-Mouth pocket probing depth (PPD)', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months.', 'description': 'Changes in full-mouth PPD (scale 0-20 mm, bigger is better), 6 sites per tooth/implant'}, {'measure': 'Number of participants with Post-operative Discomfort', 'timeFrame': '1-month follow-up', 'description': 'Patient-reported need for analgesics and type of pain medication used after the intervention.\n\nScale: yes/no, specify medication'}, {'measure': 'Full-Mouth clinical attachment levels (CAL)', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months.', 'description': 'Changes in full-mouth CAL, 6 sites per tooth/implant (scale 0-20 mm, bigger is better)'}, {'measure': 'Full-Mouth Plaque Score (FMPS)', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months.', 'description': 'Plaque levels at 6 sites per tooth/implant (1 for presence / 0 for absence, absence is better)'}, {'measure': 'Full-Mouth Bleeding Score (FMBS)', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months.', 'description': 'Changes in full-mouth bleeding score: bleeding on probing at 6 sites per tooth/implant (1 for presence / 0 for absence, absence is better).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['peri-implantitis', 'MINST', 'non-surgical therapy', 'ultrasonic debridement', 'implant dentistry', 'randomised controlled trial'], 'conditions': ['Peri-implantitis', 'Periodontitis', 'Non-surgical Periodontal Therapy']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Herrera D, et al. Management of peri-implant diseases: clinical guidelines. Journal of Clinical Periodontology. 2023'}, {'type': 'BACKGROUND', 'citation': 'European Federation of Periodontology (EFP). Guidelines for the treatment of peri-implant diseases. Periodontology 2000. 2019.'}, {'type': 'BACKGROUND', 'citation': 'Slade GD. Derivation and validation of a short-form oral health impact profile (OHIP-14). Community Dentistry and Oral Epidemiology. 1997.'}, {'type': 'BACKGROUND', 'citation': 'Guerrero A, et al. Intra- and inter-examiner reproducibility of periodontal measurements. Journal of Clinical Periodontology. 2005.'}, {'type': 'BACKGROUND', 'citation': 'Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz RI. Stratified randomization for clinical trials. Journal of Clinical Epidemiology. 1999.'}, {'type': 'BACKGROUND', 'citation': 'Blanco J, et al. Non-surgical treatment of peri-implantitis: randomized clinical trial. Journal of Clinical Periodontology. 2022.'}, {'type': 'BACKGROUND', 'citation': 'Liñares A, et al. Non-surgical therapy of peri-implantitis: clinical outcomes of ultrasonic debridement. Journal of Clinical Periodontology. 2019.'}, {'type': 'BACKGROUND', 'citation': 'Nibali L, et al. Minimally invasive non-surgical approach for periodontal intrabony defects: clinical and radiographic outcomes. Journal of Clinical Periodontology. 2015'}, {'type': 'BACKGROUND', 'citation': 'Ower P. Minimally invasive non-surgical periodontal therapy. Dental Update. 2013'}, {'type': 'BACKGROUND', 'citation': 'Ribeiro FV, et al. Minimally invasive periodontal therapy: clinical outcomes and patient-centered measures. Journal of Periodontology. 2011'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': 'Renvert S, Polyzois I, Claffey N. (2018) How do implant surface characteristics influence peri-implant disease? PMID: 29405317'}, {'pmid': '29926491', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe study includes 7 visits over 12 months, with clinical measurements, radiographs, plaque sampling, PROMs, and standardized instrumentation protocols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18\n* Peri-implantitis diagnosis (PPD \\>6 mm, BOP+, bone loss ≥3 mm)\n* Accessible implant surface without removing suprastructure\n* FMPS \\<30%, FMBS \\<30-35%\n\nExclusion Criteria:\n\n* Antibiotics in last 3 months\n* Pregnancy/lactation\n* Uncontrolled diabetes (HbA1c ≥7)\n* Long-term SPIC (\\>2 years)\n* Previous implant therapy \\<12 months\n* Smoking/vaping in last 12 months\n* Hopeless implant\n* Need for adjunctive antibiotics'}, 'identificationModule': {'nctId': 'NCT07466966', 'acronym': 'MINST vs NSPT', 'briefTitle': 'Minimally-Invasive Non-Surgical Therapy of Peri-Implantitis', 'organization': {'class': 'OTHER', 'fullName': "St. Anne's University Hospital Brno, Czech Republic"}, 'officialTitle': 'Minimally-Invasive Non-Surgical Therapy of Peri-Implantitis: A Multicenter Randomized Controlled Trial (MINST vs NSPT)', 'orgStudyIdInfo': {'id': '22KS/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard Non-Surgical Peri-implant Therapy (NSPT)', 'description': '* Ultrasonic debridement with stainless steel tips\n* Steel curettes (Columbia 4R/4L)\n* Submucosal curettage\n* Local anesthesia', 'interventionNames': ['Procedure: Non-Surgical Peri-implant Therapy (NSPT)']}, {'type': 'EXPERIMENTAL', 'label': 'Minimally-Invasive Non-Surgical Therapy (MINST)', 'description': '* Exclusive use of thin, non-diamond ultrasonic tips (PS, PL1, PL2, Siroperio, Woodpecker P3, Acteon 10Z)\n* ≥3× magnification\n* Aim to obtain stable blood clot formation', 'interventionNames': ['Procedure: Minimally-Invasive Non-Surgical Therapy (MINST)']}], 'interventions': [{'name': 'Non-Surgical Peri-implant Therapy (NSPT)', 'type': 'PROCEDURE', 'otherNames': ['NSPT'], 'description': '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.', 'armGroupLabels': ['Standard Non-Surgical Peri-implant Therapy (NSPT)']}, {'name': 'Minimally-Invasive Non-Surgical Therapy (MINST)', 'type': 'PROCEDURE', 'otherNames': ['MINST'], 'description': '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.', 'armGroupLabels': ['Minimally-Invasive Non-Surgical Therapy (MINST)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60300', 'city': 'Brno', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'MDDr. Filip Hromčík, Ph.D., MDDr., Ph.D.', 'role': 'CONTACT', 'email': 'filiphromcik@mail.muni.cz', 'phone': '+420 607987134'}, {'name': 'Petr Kořínek, MUDr.', 'role': 'CONTACT', 'email': 'petr@syndenta.cz', 'phone': '+420 773 646 646'}, {'name': 'Filip Hromčík, MDDr., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Veronika Chuchmová, Mgr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Syndenta s.r.o., Hlinky 92, 603 00 Brno, Czech Republic', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}], 'centralContacts': [{'name': 'MDDr. Filip Hromčík, Ph.D., MDDr., Ph.D.', 'role': 'CONTACT', 'email': 'filiphromcik@mail.muni.cz', 'phone': '+420 607987134'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'CSR'], 'timeFrame': 'After completion of primary analyses, expected April 2028', 'ipdSharing': 'YES', 'description': 'The following pseudonymized datasets will be shared:\n\n* Clinical measurements (PPD, CAL, BOP, plaque scores, keratinized tissue parameters)\n* Radiographic bone level measurements\n* PROMs (OHIP-14 responses)\n* Microbiological plaque analysis results\n* Treatment-related variables (treatment allocation, treatment time, need for rescue therapy)\n* Demographic and baseline characteristics (age, sex, smoking status, BMI, education level)\n\nIdentifiable personal data (name, date of birth, contact details, full medical record) will not be shared', 'accessCriteria': "Pseudonymized data from the Brno study site will be shared with the coordinating research institution:\n\nKing's College London, Faculty of Dentistry, Centre for Host-Microbiome Interactions.\n\nData may also be shared with authorized members of the multicenter research team and regulatory bodies involved in oversight.\n\nAccess will be restricted to authorized study personnel under data-sharing agreements compliant with GDPR and UK data protection regulations."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Anne's University Hospital Brno, Czech Republic", 'class': 'OTHER'}, 'collaborators': [{'name': "King's College London", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Filip Hromcik', 'investigatorAffiliation': "St. Anne's University Hospital Brno, Czech Republic"}}}}