Thermosensitive Gel With Octenidine as an Adjunct to Standard Periodontal Cleaning

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a spontaneous, postmarketing, multicenter, split-mouth randomized trial conducted nationwide in Italy. It compares the test regimen of PX-Gel added to scaling and root planing (SRP) versus SRP alone, with examiner blinding to treatment. Each participant provides at least four diseased sites in two contralateral quadrants, randomly assigned to test or control treatment. The study uses a predetermined randomization scheme to assign sides and time points for treatment assessment. The primary aim is to see if the gel enhances gingival healing after non-surgical periodontal therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centro Odontoiatrico Sforza
  Bologna, Bo, Italy Recruiting
• DIBINEM, Dental Clinic, Periodontology Department, University of Bologna
  Bologna, Bo, Italy Recruiting

Study contacts

• Study coordinator: Martina Stefanini, Dentistry
• Email: martina.stefanini2@unibo.it
• Phone: +390512088181

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.