Diabete Type 2
Conditions
Keywords
Non-surgical periodontal therapy, Pocket-X gel, periodontitis in diabetes type-2
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.
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.
Sponsors
Universita di Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | At baseline and after 2 weeks, 1 month, and 3 months | 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. |
Countries
Italy
Contacts
CONTACTAlessia Pardo
Outcome results
None listed