Pocket-X Gel Non-surgical Periodontal Therapy (DEFECT_PERIO)

University of Verona

Status: Enrolling

Conditions: Diabete Type 2

Treatments: Device: Gel therapy after non surgical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07372677

590CET

Etics Commitee (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Gel therapy after non surgical therapy

Experimental group

Description:

The test group will receive gel therapy immediately after non surgical treatment. 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.

Treatment:

Device: Gel therapy after non surgical therapy

Non surgical therapy

No Intervention group

Description:

In the control group non surgical therapy was performed using mechanical and manual instrumentations (curettes and ultrasonic devices)