Non-surgical Treatment of Peri-implant Pockets With H42 (H42)
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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Marco Morroni, PhD
- Número de teléfono: +39 0444 289366
- Correo electrónico: m.morroni@bioteck.com
Copia de seguridad de contactos de estudio
- Nombre: Anna Di Bona, PhD
- Correo electrónico: a.dibona@bioteck.com
Ubicaciones de estudio
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Seville, España, 41009
- Reclutamiento
- Faculty of Dentistry, University of Seville
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Contacto:
- Guillermo Machuca-Portillo, MD
- Número de teléfono: +34 954481128
- Correo electrónico: gmachuca@us.es
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Adult patients diagnosed with peri-implantitis and treated at the Department of Stomatology, Faculty of Dentistry, University of Seville, Spain. Participants are recruited from patients seeking care at the university dental clinic and are allocated to the study groups according to the study protocol and predefined inclusion and exclusion criteria. The study evaluates the adjunctive use of H42 hydrogel in the non-surgical treatment of peri-implantitis using a case-control design.
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_CONTROL
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
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H42 treated group
28 patients treated with ultrasonic treatment and manual curettes + H42® |
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Control group
28 patients only with ultrasonic treatment and manual curettes |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pocket Probing Depth (PPD)
Periodo de tiempo: At 1 month and 3 months in comparison with the baseline value
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The distance measured from the base of the pocket to the most apical point on the gingival margin, and it will be measured with an electronic Florida probe at controlled pressure |
At 1 month and 3 months in comparison with the baseline value
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Plaque Index (PI)
Periodo de tiempo: At 1 month and 3 months in comparison with the baseline
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For each tooth, the four-point scale Silness and Löe Plaque Index is used (Score 0: Excellent; 3: poor) |
At 1 month and 3 months in comparison with the baseline
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Degree of inflammation
Periodo de tiempo: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
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Not inflamed, mild inflamed, Moderately inflamed, Very inflamed |
Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
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NRS scale
Periodo de tiempo: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
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Numeric Rating Scale is a simple, reliable tool used to measure pain intensity on a scale from 0 to 10 (0: no pain; 10: maximum pain) |
Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
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Absence of infection
Periodo de tiempo: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
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Clinical evaluation to assess the absence of infection, specifically defined as the absence of suppuration (pus formation), at the treated site as evaluated by the Investigator. |
Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Tissue assessment
Periodo de tiempo: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
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Color, suppuration, granulation tissue, bleeding on palpation and incision margins on a five-point scale: 1 is very poor, 2 is poor, 3 is good, 4 is very good, and 5 is excellent |
Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
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Radiographic image (x-ray)
Periodo de tiempo: Baseline and 3 months follow-up
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Periapical radiographs were taken using the parallel long cone technique using a customized film-holder device and a bite block. - Bone level (BL): distance (mm) between the implant shoulder and the base of the defect. |
Baseline and 3 months follow-up
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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 Periodontol. 2018 Jun;89 Suppl 1:S313-S318. doi: 10.1002/JPER.17-0739.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 250423_H42_general
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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