Pocket-X Gel Non-surgical Periodontal Therapy

Recruiting now · Not applicable

Conditions studied: Diabete Type 2

In brief

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.

Key facts

Study ID

NCT07372677

Run by

Universita di Verona

People needed

70

Starts

2026-02-02

Expected to finish

2030-01-01

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Alessia Pardo 3494628471 Alessia.pardo@univr.it — Verona, Italy, Italy (enrolling)

Full record on ClinicalTrials.gov

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