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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Use of px gel.
- Who it may be relevant to
- Registry conditions: Periodontal Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation: a Multicenter Randomized Clinical Study
Overview
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)
Interventions
- Device Use of px gel
use of px gel in periodontal pockets
Primary outcome measures
- • Pocket depth reduction [Time frame: Baseline, 1-3-6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Italy · 2 centers
- Centro Odontoiatrico Sforza — Bologna
- DIBINEM, Dental Clinic, Periodontology Department, University of Bologna — Bologna
Identifiers
NCT: NCT07725913 · 650-2025-DISP-AUSLBO