NCT07725913 Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
| NCT ID | NCT07725913 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bologna |
| Condition | Periodontal Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-02-01 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07725913 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Periodontal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07725913 currently recruiting?
Yes, NCT07725913 is actively recruiting participants. Contact the research team at martina.stefanini2@unibo.it for enrollment information.
Where is the NCT07725913 trial being conducted?
This trial is being conducted at Bologna, Italy, Bologna, Italy.
Who is sponsoring the NCT07725913 clinical trial?
NCT07725913 is sponsored by University of Bologna. The trial plans to enroll 40 participants.