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A retrospective, observational, non-profit study designed to evaluate the use of the H42 medical device in patients with periodontitis or peri-implantitis. The study included adult subjects aged 25 to 65 years with peri-implant or periodontal pockets with probing depths (PD) between 5 and 8 mm and 1-5 defects, treated with H42® according to standard clinical practice.
The primary outcome involved comparing the periodontal parameters-Periodontal Pocket Depth (PPD), Plaque Index (PI), Clinical Attachment Level (CAL), and Sulcus Bleeding Index (SBI)-before the application of H42 (baseline) and at follow-up visits after 30 and 90 days.
The secondary outcomes, on the other hand, assessed soft tissue healing, pain levels via Numeric Rating Scale (NRS 0-10), recurrence of infection, and any unexpected side effects observed. These parameters were assessed at 7, 14, 21, 30, and 90 days after the use of H42.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periodontitis group | 28 patients affected by periodontitis ranging from stage II to IV, classified according to the 2018 EFP/AAP new classification of Periodontal and Peri-Implant Diseases and Conditions. | ||
| Peri-implantitis group | 23 patients affected by peri-implantitis with a severity grade classified according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Periodontal Pocket Depth (PPD) at 30 and 90 days | PPD defined as the distance, measured in millimeters (mm) from the gingival margin to the bottom of the gingival sulcus/pocket. | Baseline before H42 treatment; 30 days and 90 days after H42 treatment. |
| Change from Baseline in Plaque Index (PI) at 30 and 90 days | PI will be used to evaluate the presence and thickness of plaque at the gingival margin. Scoring is based on the Silness and Löe Plaque Index criteria on a scale from 0 to 3, where: 0 = no plaque; 1 = a film of plaque adhering to the free gingival margin and adjacent area of the tooth, recognized only by running a probe across the tooth surface; 2 = moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, visible to the naked eye; 3 = abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. Higher scores indicate greater plaque accumulation. The final value represents the patient's average score across all examined surfaces. | Baseline before H42 treatment; 30 days and 90 days after H42 treatment. |
| Change from Baseline in Clinical Attachment Level (CAL) at 30 and 90 days | CAL will be evaluated to assess periodontal tissue regeneration. Measurement is calculated using the formula: CAL = PPD - (CEJ to FGM distance), where PPD is Probing Pocket Depth, CEJ is Cemento-Enamel Junction, and FGM is Free Gingival Margin. Measurements will be taken in millimeters (mm). | Baseline before H42 treatment; 30 days and 90 days after H42 treatment. |
| Change from Baseline in Sulcus Bleeding Index (SBI) at 30 ad 90 days | SBI evaluated as ordinal variable with a scale from 0 to 5, where: 0 = gingiva of normal texture, color, no bleeding; 1 = gingiva apparently normal, bleeding on probing; 2 = bleeding on probing, color change, no edema; 3 = bleeding on probing, color change, slight edema; 4 = either bleeding on probing, color change, obvious edema; 5 = spontaneous bleeding on probing, color change. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Patient-Reported Pain Score at five predefined follow-up timepoint | Patient-reported pain will be assessed using an 11-point Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst possible pain". Higher scores represent greater pain intensity. | Baseline before H42 treatment and at 7, 14, 21, 30, and 90 days after the use of H42. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects aged 25 to 65 years with peri-implant or periodontal pockets with probing depths (PD) between 5 and 8 mm and 1-5 defects, treated with H42 according to standard clinical practice in three dental clinics located in Italy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Studi Odontoiatrici Papa e Di Stefano | Caserta | CE | 81100 | Italy | ||
| Studio Odontoiatrico Dott. G. Tarquini |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32794356 | Background | Hentenaar DFM, De Waal YCM, Van Winkelhoff AJ, Meijer HJA, Raghoebar GM. Non-surgical peri-implantitis treatment using a pocket irrigator device; clinical, microbiological, radiographical and patient-centred outcomes-A pilot study. Int J Dent Hyg. 2020 Nov;18(4):403-412. doi: 10.1111/idh.12462. Epub 2020 Sep 11. | |
| 32957945 | Background |
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| ID | Term |
|---|---|
| D010514 | Periodontal Pocket |
| D057873 | Peri-Implantitis |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Baseline before H42 treatment; 30 days and 90 days after H42 treatment. |
| Change from baseline in inflammation grade at five predefined follow-up timepoints | Inflammation was assessed using the Gingival Index (GI), a scale ranging from 0 to 3, where GI = 0 indicates the absence of inflammation, GI = 1 indicates mild inflammation, GI = 2 indicates moderate inflammation, and GI = 3 indicates severe inflammation. Higher scores indicate greater nflammation. | Baseline before H42 treatment and at 7, 14, 21, 30, and 90 days after the use of H42. |
| Change from Baseline in soft tissue healing at five predefined follow-up timepoint | Soft tisssue healing was assessed using a scale ranging from 0 to 3, where 0 indicates the absence of healing, 3 indicates severe healing. | Baseline before H42 treatment and at 7, 14, 21, 30, and 90 days after the use of H42. |
| Roma |
| RM |
| 00179 |
| Italy |
| Studio odontoiatrico Sao di De Rosa Nicola e Del Giudice Marina | Naples | 80122 | Italy |
| Ma L, Diao X. Effect of chlorhexidine chip as an adjunct in non-surgical management of periodontal pockets: a meta-analysis. BMC Oral Health. 2020 Sep 21;20(1):262. doi: 10.1186/s12903-020-01247-8. |
| 32882741 | Background | Rokaya D, Srimaneepong V, Wisitrasameewon W, Humagain M, Thunyakitpisal P. Peri-implantitis Update: Risk Indicators, Diagnosis, and Treatment. Eur J Dent. 2020 Oct;14(4):672-682. doi: 10.1055/s-0040-1715779. Epub 2020 Sep 3. |
| 26255984 | Background | Robitaille N, Reed DN, Walters JD, Kumar PS. Periodontal and peri-implant diseases: identical or fraternal infections? Mol Oral Microbiol. 2016 Aug;31(4):285-301. doi: 10.1111/omi.12124. Epub 2015 Sep 15. |
| 25495683 | Background | Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334. |
| 29926489 | Background | Caton JG, Armitage G, Berglundh T, Chapple ILC, Jepsen S, Kornman KS, Mealey BL, Papapanou PN, Sanz M, Tonetti MS. A new classification scheme for periodontal and peri-implant diseases and conditions - Introduction and key changes from the 1999 classification. J Clin Periodontol. 2018 Jun;45 Suppl 20:S1-S8. doi: 10.1111/jcpe.12935. |
| 32198347 | Background | Chatzigiannidou I, Teughels W, Van de Wiele T, Boon N. Oral biofilms exposure to chlorhexidine results in altered microbial composition and metabolic profile. NPJ Biofilms Microbiomes. 2020 Mar 20;6(1):13. doi: 10.1038/s41522-020-0124-3. |
| 11585783 | Background | Loesche WJ, Grossman NS. Periodontal disease as a specific, albeit chronic, infection: diagnosis and treatment. Clin Microbiol Rev. 2001 Oct;14(4):727-52, table of contents. doi: 10.1128/CMR.14.4.727-752.2001. |
| 34839889 | Background | Kwon T, Lamster IB, Levin L. Current Concepts in the Management of Periodontitis. Int Dent J. 2021 Dec;71(6):462-476. doi: 10.1111/idj.12630. Epub 2021 Feb 19. |
| 28758294 | Background | Slots J. Periodontitis: facts, fallacies and the future. Periodontol 2000. 2017 Oct;75(1):7-23. doi: 10.1111/prd.12221. |
| 29926951 | Background | Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721. |
| 25261053 | Background | Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26. |