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)
Studie Overzicht
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Martina Stefanini, Dentistry
- Telefoonnummer: +390512088181
- E-mail: martina.stefanini2@unibo.it
Studie Locaties
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BO
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Bologna, BO, Italië, 40124
- Werving
- Centro Odontoiatrico Sforza
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Contact:
- Nicola Sforza, Dentistry
- Telefoonnummer: +39051222542
- E-mail: segreteria@co-s.it
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Bologna, BO, Italië, 40125
- Werving
- DIBINEM, Dental Clinic, Periodontology Department, University of Bologna
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Contact:
- Martina Stefanini, Dentistry
- Telefoonnummer: +390512088181
- E-mail: martina.stefanini2@unibo.it
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Use of PX gel
Px gel applied in periodontal pockets
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use of px gel in periodontal pockets
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Placebo-vergelijker: No use of Px gel
No use of px gel
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use of px gel in periodontal pockets
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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• Pocket depth reduction
Tijdsspanne: 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.
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Baseline, 1-3-6 months
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 650-2025-DISP-AUSLBO
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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