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 (PX-2025)
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.
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)
Studieöversikt
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Martina Stefanini, Dentistry
- Telefonnummer: +390512088181
- E-post: martina.stefanini2@unibo.it
Studieorter
-
-
BO
-
Bologna, BO, Italien, 40124
- Rekrytering
- Centro Odontoiatrico Sforza
-
Kontakt:
- Nicola Sforza, Dentistry
- Telefonnummer: +39051222542
- E-post: segreteria@co-s.it
-
Bologna, BO, Italien, 40125
- Rekrytering
- DIBINEM, Dental Clinic, Periodontology Department, University of Bologna
-
Kontakt:
- Martina Stefanini, Dentistry
- Telefonnummer: +390512088181
- E-post: martina.stefanini2@unibo.it
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Use of PX gel
Px gel applied in periodontal pockets
|
use of px gel in periodontal pockets
|
|
Placebo-jämförare: No use of Px gel
No use of px gel
|
use of px gel in periodontal pockets
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
• Pocket depth reduction
Tidsram: 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.
|
Baseline, 1-3-6 months
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 650-2025-DISP-AUSLBO
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .