Pocket-X Gel Non-surgical Periodontal Therapy

NCT07372677 | Recruiting

• 2 other identifiers: 590CETEtics Commitee
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabete Type 2

Keywords

Non-surgical periodontal therapy; Pocket-X gel; periodontitis in diabetes type-2

Outcome Measures

Primary Outcomes (1)

• Clinical evaluation, in the test site and in the control site (for each of the two groups) of the periodontal index of: PPD in mm.

  Clinical evaluation, in the test site and in the control site (for each of the two groups), at baseline and after 2 weeks, 1 month, and 3 months, by means of detection with a periodontal millimeter probe, of the periodontal index of: pocket probing depth (PPD), in mm. Detect whether the healing of periodontal defects is different from a clinical and microbiological point of view between patients with T2DM and non-diabetic patients; whether periodontal treatment and maintenance can bring improvement of conditions and stability over time also for the diabetic condition.

  At baseline and after 2 weeks, 1 month, and 3 months

Study Arms (2)

Gel therapy after non surgical therapy

EXPERIMENTAL

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.

Device: Gel therapy after non surgical therapy

Non surgical therapy

NO INTERVENTION

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

Interventions

Gel therapy after non surgical therapy DEVICE

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.

Gel therapy after non surgical therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Alessia Pardo 3494628471 Alessia.pardo@univr.it

Verona, Italy, 37134, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Alessia Pardo

CONTACT

+39 3494628471; Alessia.pardo@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Researcher

Model Details: The study is clinical, with the following characteristics: prospective, case-control, single-center, with a post-market device. The case group is represented by patients affected by controlled T2DM, the control group by non-diabetic patients.

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 28, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

IT (1)