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| Name | Class |
|---|---|
| King's College London | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Non-Surgical Peri-implant Therapy (NSPT) | Experimental |
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| Minimally-Invasive Non-Surgical Therapy (MINST) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pocket closure at test site (implant site) - defined as 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 3 months, 6 months, 9 months, 12 months |
| Change in Clinical Attachment Level (CAL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MDDr. Filip Hromčík, Ph.D., MDDr., Ph.D. | Contact | +420 607987134 | filiphromcik@mail.muni.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syndenta s.r.o., Hlinky 92, 603 00 Brno, Czech Republic | Recruiting | Brno | 60300 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 9332805 | Background | 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. | |
| Background | Guerrero A, et al. Intra- and inter-examiner reproducibility of periodontal measurements. Journal of Clinical Periodontology. 2005. | ||
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The following pseudonymized datasets will be shared:
Identifiable personal data (name, date of birth, contact details, full medical record) will not be shared
After completion of primary analyses, expected April 2028
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.
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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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.
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| 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. |
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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 | 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 |
| 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 | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months |
| 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 onyl once, during the intervention |
| 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 | Up to 12 months. |
| Full-Mouth pocket probing depth (PPD) | 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 | 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) | 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. |
| Full-Mouth Plaque Score (FMPS) | 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) | 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. |
| Background |
| 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. |
| 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. |
| 26257238 | Background | 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. |
| 23829010 | Background | 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. |
| Background | Ribeiro FV, et al. Minimally invasive periodontal therapy: clinical outcomes and patient-centered measures. Journal of Periodontology. 2011 |
| 29926491 | 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. |
| 21323717 | Background | 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. |