Periodontal DiseasePX-2025NCT07725913
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
A study testing Use of px gel in people with Periodontal Disease, run by University of Bologna at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- Use of px gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Feb 2026to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- • 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
Show all 14Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Centro Odontoiatrico Sforza
Bologna, BO, 40124
Nicola Sforza, Dentistry, +39051222542, segreteria@co-s.it
- Recruiting
DIBINEM, Dental Clinic, Periodontology Department, University of Bologna
Bologna, BO, 40125
Martina Stefanini, Dentistry, +390512088181, martina.stefanini2@unibo.it
About this study
Official title: 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.
Read more
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)
- Conditions
- Periodontal Disease
- Being tested
- Use of px gel
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of px gelDevice
use of px gel in periodontal pockets in the PX arm
| Study group | Role | What they receive |
|---|---|---|
| Use of PX gel | Experimental | Px gel applied in periodontal pockets Receives: Device: Use of px gel |
| No use of Px gel | Placebo comparator | No use of px gel Receives: Device: Use of px gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Pocket depth change
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.
Measured: Baseline, 1-3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Feb 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Stefanini, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725913
- Sponsor's protocol ID
- 650-2025-DISP-AUSLBO
- Acronym
- PX-2025
- Status last verified
- Nov 2026
- First submitted
- 21 Jul 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation: a Multicenter Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07725913
- Acronym / sponsor ID
- PX-2025 / 650-2025-DISP-AUSLBO
- Conditions
- Periodontal Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of PX gel | Experimental | Device: Use of px gelPx gel applied in periodontal pockets |
| No use of Px gel | Placebo comparator | Device: Use of px gelNo use of px gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- • Pregnancy (confirmed, suspected, or uncertain), breastfeeding, or intention to become pregnant during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of px geluse of px gel in periodontal pockets in the PX arm | Device | No use of Px gel, Use of PX gel |
Primary outcome
• Pocket depth change
Time frame: Baseline, 1-3-6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of px gel in people with Periodontal Disease, run by University of Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martina Stefanini, Dentistry (+390512088181, martina.stefanini2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Pocket depth change (time frame: Baseline, 1-3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.