Pocket‑X gel added to non-surgical gum treatment for people with type 2 diabetes
Clinical and Microbiological Effects of a Thermal-Gel Device in Periodontal Treatment: Diabetic vs Non-Diabetic Patients
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Universita di Verona Academic / other |
| Locations | 1 site (Verona, Italy) |
| Trial ID | NCT07372677 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Verona, Italy
- Alessia Pardo 3494628471 Alessia.pardo@univr.it — Verona, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Alessia Pardo
- Email: Alessia.pardo@univr.it
- Phone: +39 3494628471
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.