NCT07372677Recruiting
Pocket-X Gel Non-surgical Periodontal Therapy
Clinical and Microbiological Effects of a Thermal-Gel Device in Periodontal Treatment: Diabetic vs Non-Diabetic Patients
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 19 Jan 2026
- Start date
- 2 Feb 2026
- Primary completion date
- Jan 2028
- Lead sponsor
- Universita di Verona
- Diseases
- Type 2 diabetes
- NCT number
- NCT07372677
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 2 Feb 2026 to the primary completion date, Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alessia Pardo 3494628471 Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.