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PX-2025Thermosensitive Hyaluronic Gel With Octenidine for Periodontitis Treatment

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Study Aim

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.

What is being tested

Applying Px Gel to Gums

+ Applying Px Gel to Gums

Device
Who is being recruted

Stomatognathic Diseases

+ Mouth Diseases

+ Periodontal Diseases

Over 18 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: February 2026
See protocol details

Summary

Principal SponsorUniversity of Bologna
Study ContactMartina Stefanini, DentistryMore contacts
Last updated: July 24, 2026
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorUniversity of Bologna
Study ContactMartina Stefanini, DentistryMore contacts
Last updated: July 24, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Stomatognathic DiseasesMouth DiseasesPeriodontal Diseases

Criteria

6 inclusion criteria required to participate
>= 20 existing teeth (wisdom teeth excluded)

Age 18 years or older

Diagnosis of periodontitis stage II-III or IV (any grade) of periodontitis

Each participant should have 2 or more contralateral quadrants with a minimum of 4 qualifying pockets of >= 5 mm that bled on probing

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14 exclusion criteria prevent from participating
Chronic diseases such as uncontrolled diabetes mellitus (HbA1c >= 7.0%) or rheumatoid arthritis

Heavy smoking (more than 10 cigarettes/day)

History of radiotherapy or chemotherapy

Mental disorders

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants in this group receive PX gel applied to their periodontal pockets.

Group II

Placebo
Participants in this group do not use Px gel in their periodontal pockets.

Study 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

Recruiting

Centro Odontoiatrico Sforza

Bologna, ItalyOpen Centro Odontoiatrico Sforza in Google Maps
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DIBINEM, Dental Clinic, Periodontology Department, University of Bologna

Bologna, Italy
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2 Study Centers