PX-2025Thermosensitive Hyaluronic Gel With Octenidine for Periodontitis Treatment
This study aims to treat periodontitis by using a thermosensitive hyaluronic gel with octenidine, with the main goal of reducing the depth of periodontal pockets, which will be measured at six sites around each tooth.
Applying Px Gel to Gums
+ Applying Px Gel to Gums
Stomatognathic Diseases
+ Mouth Diseases
+ Periodontal Diseases
Treatment Study
Summary
Study start date: February 1, 2026
Actual date on which the first participant was enrolled.This study is about testing the effectiveness of a thermosensitive hyaluronic gel with octenidine, known as PX-Gel, when used alongside scaling and root planing (SRP), a standard non-surgical treatment for periodontitis. The trial is specifically for adult patients with periodontitis stage II-III or IV, who have at least 20 existing teeth and a minimum of 4 pockets of 5 mm or more that bleed on probing. The goal is to see if PX-Gel can enhance gingival healing and reduce pocket depth when used as an adjunct to SRP. This is important as it could potentially improve the care and treatment outcomes for people suffering from periodontitis. During the study, each patient will have at least 4 sites with a pocket depth more than 5 mm and positive bleeding on probing in 2 contralateral quadrants. These sites will be randomly assigned to receive either the test treatment (SRP + PX-Gel) or serve as controls (SRP only). The treatment assignment will be concealed in opaque sealed envelopes and revealed only after the SRP session. The effectiveness of the treatment will be measured by the reduction in pocket depth, using a light probing force with a 1-mm periodontal probe at six sites around each tooth. Patients will not be informed where the treatment gel is applied. The study ensures blinding of the independent examiner throughout the study period.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
DIBINEM, Dental Clinic, Periodontology Department, University of Bologna
Bologna, Italy