NCT07372677 Pocket-X Gel Non-surgical Periodontal Therapy
| NCT ID | NCT07372677 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universita di Verona |
| Condition | Diabete Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2026-02-02 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07372677 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Diabete Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07372677 currently recruiting?
Yes, NCT07372677 is actively recruiting participants. Contact the research team at Alessia.pardo@univr.it for enrollment information.
Where is the NCT07372677 trial being conducted?
This trial is being conducted at Verona, Italy.
Who is sponsoring the NCT07372677 clinical trial?
NCT07372677 is sponsored by Universita di Verona. The trial plans to enroll 70 participants.