Pocket-X Gel Non-surgical Periodontal Therapy

Официальное название

Clinical and Microbiological Effects of a Thermal-Gel Device in Periodontal Treatment: Diabetic vs Non-Diabetic Patients

Обзор

Evaluate from a clinical and microbiological point of view the effect of an adjunctive therapy based on a thermal-gelling device Pocket-X® Gel (Hyaluronic acid, Poloxamer, 2-Phenoxyethanol, Octedine HCL, Water), in the non-surgical treatment of periodontal defects, in a population of patients with T2DM compared to non-diabetic patients. Determine whether periodontal defect healing is clinically and microbiologically different between T2DM patients and non-diabetic patients; whether periodontal treatment and maintenance can lead to improvement of conditions and stability over time also for diabetic conditions.

Вмешательства

• Устройство Gel therapy after non surgical therapy
  The gel in use is a composition of Hyaluronic acid, Poloxamer, 2-Phenoxyethanol, Octedine HCL,Water (Pocket-X Gel Geistlich AG, Wolhusen, Switzerland). It is a patented liquid-to-gel device. Pocket-X® Gel is composed of: Poloxamer 407 with thermo-gelling properties, Octenidine, antimicrobial preservative, Hyaluronic acid to support tissue healing. It promotes gingival healing and prevents bacterial recolonization of periodontal pockets, forming a protective physical barrier, allows to postpone o

Первичные конечные точки

• Clinical evaluation, in the test site and in the control site (for each of the two groups) of the periodontal index of: PPD in mm. [Срок оценки: At baseline and after 2 weeks, 1 month, and 3 months]

Критерии участия

Критерии включения

Patients normally eligible for the visit and for the non-surgical type of treatment for periodontal defects:

• patients with an age between 18 and 80;
• patients with: (i) Asa status I (no functional impairment due to pathologies), (ii) patients with type 2 diabetes (T2DM) with: glycated hemoglobin level HbA1c between 6.5 and 8.0%, on dietary therapy and/or with hypoglycemic drugs in regular follow-up at the diabetes service;
• patients with chronic periodontitis stage 3 or 4, according to the new classification of periodontal diseases \[Tonetti et al.\]), verified clinically and radiographically: patients will be selected with interdental clinical attachment level (CAL) at the site of greatest loss ≥3 mm to ≥2 non-adjacent teeth, probing depth (PPD) ≥5 mm, bleeding on probing (BoP) and horizontal and/or vertical radiographic bone loss.

Критерии исключения

• Patients not eligible for the non-surgical type of treatment for periodontal defects:

• patients with a positive history of diseases with functional impairment (ASA status 2,3,4) or severe handicaps that could limit the ability to attend appointments;
• patients with uncontrolled/poorly controlled DM at the time of study selection (e.g. type 1 diabetes mellitus and secondary forms of diabetes); patients with uncontrolled and serious diabetic complications (cardiovascular, renal, hepatic and nervous);
• poor compliance with treatment, with poor oral hygiene and motivation;
• not signing informed consent by patients.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Alessia Pardo 3494628471 Alessia.pardo@univr.it — Verona

Идентификаторы

NCT: NCT07372677 · 590CET · Etics Commitee

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗