Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation. Spontaneous, Postmarketing Trial With a Medical Device (MD), Split-mouth, Nationwide Multicenter Study Single-blind Randomized Controlled Trial (PX-2025)

Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation: a Multicenter Randomized Clinical Study

This will be a spontaneous, postmarketing trial with a medical device (MD), split-mouth, nationwide multicenter study (coordinator center: Periodontal Unit, Dental Clinic, DIBINEM, Bologna University, Italy, with satellite center involved), single-blind (examiner), randomized controlled trial comparing, at different time points, the clinical efficacy of PX-Gel-a thermosensitive hyaluronic acid-octenidine gel-in enhancing gingival healing of periodontal pockets when used as an adjunct to scaling and root planing (test group) versus conventional SRP (control group). SRP represents the gold standard for non-surgical treatment of periodontitis and it is the standard of care.

Each patient will contribute with at least 4 sites with a PD more than 5 mm and positive BOP in 2 contralateral quadrants. The sites will be randomly assigned to one of the two treatment regimens, using a predetermined computer- generated randomization scheme, regarding left or right side) to receive the test treatment (SRP + PX-gel) or to serve as SRP controls.

Allocation concealment will be performed by opaque sealed envelopes, sequentially numbered. The allocation sequence will be generated by means of a computer-generated random list (https ://www.sealedenve lope.com/simple-randomiser/ v1/) and a different subject (not involved in the treatment) will be instructed to assign a sealed envelope containing the treatments of each site (SRP+ PX-Gel or SRP). The opaque sealed envelope will be opened immediately after the end of the SRP session.

Blinding of independent examiner will be maintained through-out all study period.

The patients will not be informed of the locations where the treatment gel will be applied.

All adult subjects referred to the Periodontal Unit and involved satellite center for periodontal treatment will be screened and enrolled in the study according to the following inclusion/exclusion criteria:

• Patients agreeing to participate in the study
• Age 18 years or older
• ≥ 20 existing teeth (wisdom teeth excluded).
• 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
• Full-mouth parallel periapical X-rays demonstrating bone loss (standard of care)

Study Overview

• Status: Recruiting
• Conditions: Periodontal Disease
• Intervention / Treatment: Device: Use of px gel

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martina Stefanini, Dentistry; Phone Number: +390512088181; Email: martina.stefanini2@unibo.it

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40124
      • Recruiting
      • Centro Odontoiatrico Sforza
      • Contact: Nicola Sforza, Dentistry; Phone Number: +39051222542; Email: segreteria@co-s.it
    • Bologna, BO, Italy, 40125
      • Recruiting
      • DIBINEM, Dental Clinic, Periodontology Department, University of Bologna
      • Contact: Martina Stefanini, Dentistry; Phone Number: +390512088181; Email: martina.stefanini2@unibo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients agreeing to participate in the study
• Age 18 years or older
• ≥ 20 existing teeth (wisdom teeth excluded).
• 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
• Full-mouth parallel periapical X-rays demonstrating bone loss (standard of care)

Exclusion Criteria:

• • Pregnancy (confirmed, suspected, or uncertain), breastfeeding, or intention to become pregnant during the study period

  • No antibiotic and periodontal therapy within the last 6 months
  • Heavy smoking (more than 10 cigarettes/day)
  • Chronic diseases such as uncontrolled diabetes mellitus (HbA1c ≥ 7.0%) or rheumatoid arthritis
  • History of radiotherapy or chemotherapy
  • Mucosal immune diseases
  • Mental disorders
  • Parafunctional habits such as bruxism
  • Subjects with removable partial dentures
  • Patients undergoing orthodontic therapy
  • Sites next to recent extraction sockets
  • Teeth showing endodontic-periodontic lesions
  • Systemically healthy and no known allergies
  • Subjects with a known hypersensitivity to hyaluronic acid or to any of the ingredients contained in the product formulation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Use of PX gel; Px gel applied in periodontal pockets	Device: Use of px gel; use of px gel in periodontal pockets
Placebo Comparator: No use of Px gel; No use of px gel	Device: Use of px gel; use of px gel in periodontal pockets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Pocket depth reduction	will be measured using light probing force (approximately 25 gr) with a 1-mm periodontal probe at six sites around each tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual, distolingual/palatal, midlingual/palatal). A full mouth periodontal chart is done at preliminary visit for screening and periodontal diagnosis.	Baseline, 1-3-6 months

Collaborators and Investigators

• Sponsor: University of Bologna

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontal Diseases
• Other Study ID Numbers: 650-2025-DISP-AUSLBO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No