Pocket-X Gel Non-surgical Periodontal Therapy
ConditionDiabete Type 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversita di Verona
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Gel therapy after non surgical therapy
DeviceThe 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Gel therapy after non surgical therapyExperimental treatment 1 intervention
Group B: Non surgical therapyNo intervention 0 interventions
Trial outcomes
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.
Time frame
At baseline and after 2 weeks, 1 month, and 3 monthsSponsors and contacts
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Source ClinicalTrials.gov