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Clinical trial Recruiting at 1 site Interventional Ages 18 to 80

Pocket‑X gel added to non-surgical gum treatment for people with type 2 diabetes

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

Run by Universita di Verona · NCT07372677 · Data updated 2026-11-12

This will try adding Pocket‑X gel after standard non-surgical gum cleaning to see if it helps periodontal defects heal better in adults with type 2 diabetes compared with people without diabetes.

More Diabete Type 2 trials

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment70 (estimated)
SponsorUniversita di Verona
Academic / other
Locations1 site (Verona, Italy)
StatusRecruiting
StartedFebruary 2, 2026
Main results expectedJanuary 2028
Study endsJanuary 2030
Registry record updatedMay 29, 2026
Trial IDNCT07372677 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–80 with stage 3–4 chronic periodontitis (PPD ≥5 mm, CAL loss ≥3 mm at sites on at least two non-adjacent teeth, bleeding on probing and radiographic bone loss) and either well-controlled type 2 diabetes (HbA1c 6.5–8.0% on diet or hypoglycemic drugs) or no diabetes are ideal candidates.

Probably not a fit

Patients with uncontrolled diabetes (HbA1c >8%), those not eligible for non-surgical periodontal therapy, or those outside the 18–80 age range are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study applies a thermally gelling topical product (Pocket‑X Gel: hyaluronic acid, poloxamer, 2‑phenoxyethanol, octenidine HCl, water) as an adjunct after standard non-surgical periodontal therapy in adults with chronic periodontitis. It enrolls both people with type 2 diabetes (HbA1c 6.5–8.0%) and non-diabetic controls to compare clinical and microbiological healing. Clinical endpoints include probing pocket depth, clinical attachment level, bleeding on probing and radiographic bone changes, and microbiological sampling of periodontal sites; metabolic status will be monitored in the diabetic group. Participants are followed through treatment and maintenance to evaluate the stability of outcomes over time.

Why it matters

Potential benefit: If successful, the adjunctive gel could improve periodontal healing and stability in people with type 2 diabetes, potentially reducing gum inflammation and bacterial load.

How similar studies have gone: Previous trials of hyaluronic-acid–based and antiseptic adjuncts have shown modest clinical and microbiological benefits in periodontitis, but evidence specifically in people with type 2 diabetes is limited.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Alessia Pardo 3494628471 Alessia.pardo@univr.it
    Verona, Italy, Italy     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Diabete Type 2 24Universita di Verona 15
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.