Pocket-X Gel Non-surgical Periodontal Therapy

Universita di Verona70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabete Type 2

Interventions

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 or avoid long, complex and painful surgeries, ensuring the success of periodontal treatment, delaying any surgical interventions.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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.

Clinical evaluation, in the test site and in the control site (for each of the two groups), at baseline and after 2 weeks, 1 month, and 3 months, by means of detection with a periodontal millimeter probe, of the periodontal index of: pocket probing depth (PPD), in mm. Detect whether the healing of periodontal defects is different from a clinical and microbiological point of view between patients with T2DM and non-diabetic patients; whether periodontal treatment and maintenance can bring improvement of conditions and stability over time also for the diabetic condition.

Time frame: At baseline and after 2 weeks, 1 month, and 3 months