Non-surgical Treatment of Peri-implant Pockets With H42

Обзор

This prospective, observational study evaluates the efficacy and safety of H42 non-surgical treatment for peri-implant pockets. The trial involves 56 patients, with 28 subjects receiving the H42 treatment and 28 acting as a control group to monitor soft tissue healing and bone level changes. Clinical outcomes focus on Pocket Probing Depth (PPD) and Silness and Löe Plaque Index (PI) measured at baseline, 1 month, and 3 months. Gingival inflammation, pain intensity on a 0-10 NRS scale, and absence of infection are monitored at baseline, 7, 14, and 21 days, and at 1 and 3 months. Additionally, a five-point tissue assessment evaluates color, suppuration, granulation tissue, bleeding, and incision margins. Radiographic analysis at baseline and 3 months uses standardized periapical x-rays to measure bone level, intra-bony defect height, width, and angulation. Safety is assessed through the continuous registration of adverse events.

Первичные конечные точки

• Pocket Probing Depth (PPD) [Срок оценки: At 1 month and 3 months in comparison with the baseline value]
• Plaque Index (PI) [Срок оценки: At 1 month and 3 months in comparison with the baseline]
• Degree of inflammation [Срок оценки: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up]
• NRS scale [Срок оценки: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up]
• Absence of infection [Срок оценки: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up]

Вторичные конечные точки (2)

• Tissue assessment [Срок оценки: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up]
• Radiographic image (x-ray) [Срок оценки: Baseline and 3 months follow-up]

Критерии участия

Критерии включения

• Men or women with age ≥ 25 and ≤ 65 years.
• Subjects affected by peri-implant pockets with probing depth (PD) in the range between 6 to 8 mm.
• Each subject can have from 1 to 5 defects.
• Subjects willing to provide signed informed consent to clinical investigation participation.

Критерии исключения

• Use of aspirin and antiplatelet agents a week before treatment.
• Subjects smokers ≥ 10 cigarettes per day.
• Subjects presenting current or previous bleeding disorders.
• Subjects taking or having indications for anticoagulant therapy.
• Concomitant treatments or procedures to improve gum health over the last six months before the clinical investigation enrolment, such as HA gel treatments, injection of fillers, and surgery.
• Subjects suffering from infectious diseases, including herpes simplex infection, active hepatitis, or human immunodeficiency virus.
• Subjects with dental aesthetic surgery in the preceding 12 months before the clinical investigation enrolment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Испания · 1 центр

• Faculty of Dentistry, University of Seville — Seville

Публикации

• Herrera D, Berglundh T, Schwarz F, Chapple I, Jepsen S, Sculean A, Kebschull M, Papapanou PN, Tonetti MS, Sanz M; EFP workshop participants and methodological consultant. Prevention and treatment of peri-implant diseases-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2023 Jun;50 Suppl 26:4-76. doi: 10.1111/jcpe.13823. Epub 2023 Jun 4. PMID 37271498
• Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Periodontol. 2018 Jun;89 Suppl 1:S267-S290. doi: 10.1002/JPER.16-0350. PMID 29926957
• 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 Classificati PMID 29926955
• 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. PMID 32882741
• 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. PMID 26255984
• 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. PMID 25495683
• 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. PMID 29926489

Идентификаторы

NCT: NCT07680491 · 250423_H42_general

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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