Pocket-X Gel Non-surgical Periodontal Therapy
Recruiting · NCT07372677 · Interventional (participants receive a specific treatment) · Lead sponsor: Universita di Verona
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed.
- Alessia Pardo 3494628471 [email protected] - Verona, Italy, Italy