RecruitingNot ApplicableNCT07372677

Pocket-X Gel Non-surgical Periodontal Therapy

Clinical and Microbiological Effects of a Thermal-Gel Device in Periodontal Treatment: Diabetic vs Non-Diabetic Patients


Sponsor

Universita di Verona

Enrollment

70 participants

Start Date

Jun 3, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether Pocket-X Gel — a treatment applied directly into the gum pockets during a standard dental cleaning — can improve outcomes for people with advanced gum disease (periodontitis), particularly those who also have type 2 diabetes. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with stage 3 or 4 chronic periodontitis (advanced gum disease) - You are either in good general health with no major conditions, OR you have well-controlled type 2 diabetes (HbA1c between 6.5–8.0%) managed with diet or medication - You have gum pockets deep enough to require non-surgical treatment **You may NOT be eligible if...** - You have type 1 diabetes or poorly controlled diabetes with serious complications - You have a health condition that significantly affects your daily function - You have poor oral hygiene or are unlikely to attend appointments - You are currently pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGel therapy after non surgical therapy

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.


Locations(1)

Alessia Pardo 3494628471 Alessia.pardo@univr.it

Verona, Italy, Italy

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NCT07372677


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