ClinicalTrials.gg
Sign In
RecruitingNCT07725913PX-2025Updated Nov 6, 2026

Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation

An interventional study of Use of px gel in Periodontal Disease, sponsored by University of Bologna. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by University of Bologna · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Feb 2026, registered Jul 2026).
  • Started Feb 2026; still recruiting 9 months later.
Updated Nov 6, 2026Primary outcomes revisedTitle changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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)
02

Conditions studied

  • Periodontal Disease

Browse trials for

03

In context

Periodontal Diseases

867 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.

This study's planned enrollment of 40 is below the median of 45 across 557 interventional studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

University of Bologna is the lead sponsor of 158 studies on the registry; 24 are open to participants now.

Browse University of Bologna studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 ( ≥ 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 to hyaluronic acid or to any of the ingredients contained in the product formulation.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Use of PX gel

    Px gel applied in periodontal pockets

    Device: Use of px gel

  • Placebo comparator
    No use of Px gel

    No use of px gel

    Device: Use of px gel

Interventions

  • DeviceUse of px gel

    use of px gel in periodontal pockets in the PX arm

06

What researchers measure

Primary outcomes

  1. • 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.

    Time frame: Baseline, 1-3-6 months

07

Study locations

2 of 2 sites recruiting
  • Centro Odontoiatrico Sforza
    Bologna, BO 40124, Italy
    Recruiting
  • DIBINEM, Dental Clinic, Periodontology Department, University of Bologna
    Bologna, BO 40125, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Feb 2027, 12 months after the start.

Of 312 non-industry interventional studies with no phase under Periodontal Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 27. This study's planned 12 months is close to that.

Counting every sponsor, half of 331 studies reached it within 13 months; a quarter within 8 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2026
First posted
Jul 24, 2026
StartActual
Feb 1, 2026
Primary completionEst.
Feb 1, 2027
CompletionEst.
Feb 1, 2028
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary outcomes
1 edited
What changed in the outcomes
  • Edited• Pocket depth reductionchangeTime frame: Baseline, 1-3-6 months
Nov 6, 2026
Title
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→Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Primary outcomes 1 edited
    What changed in the outcomes
    • Edited• Pocket depth reductionchangeTime frame: Baseline, 1-3-6 months
    Title 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→Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
    + 2 other changes: verification date and arm descriptions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07725913
Lead sponsor
University of Bologna
Responsible party
Martina Stefanini (Professor, University of Bologna) — Principal investigator
First posted
Jul 24, 2026
Start date
Feb 1, 2026
Primary completion
Feb 1, 2027 (estimated)
Completion
Feb 1, 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

Martina Stefanini, Dentistry
Contact
martina.stefanini2@unibo.it
+390512088181

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Periodontal Diseases →

Other studies from this sponsor

University of Bologna →

Start the discussion