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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

RecruitingNAAges 18 Years - anyAllUniversity of Bologna
NCT07725913 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Use of px gel
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Where

2 sites
Centro Odontoiatrico Sforza
Bologna, Italy
DIBINEM, Dental Clinic, Periodontology Department, University of Bologna
Bologna, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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