Clinical Trial

Hyaluronic Acid and Polynucleotides in Ridge Preservation

Study acronym: P-005
Recruiting
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Summary
The aim of this study is to test the use of a bovine-derived bone graft combined with a polynucleotides-rich hyaluronic acid (PNHA) gel for the preservation of the bone after a tooth extraction (alveolar ridge preservation) and to test the performance of a fully-digital workflow to rehabilitate the site with a dental implant. 40 patients in need for a single tooth extraction will be recruited at Centro di Odontoiatria, Università di Parma and they will be randomly assigned to 2 groups: extraction and spontaneous healing or extraction and regeneration of the site with a bovine-derived bone graft combined with a PNHA gel. At 4 months after extraction an implant will be placed in the extraction site, which will be rehabilitated with a fully-digital workflow and patients will be followed up at up to 12 months post rehabilitation. Two 3D x-rays with a small field of view will be performed immediately after extraction and at 4 months post extraction to plan implant placement. These images will also be used to assess changes in the dimension of the post extraction bone (primary outcome). As part of the study different questionnaires will be administered to assess quality of life and perception of the therapy and the wound exudate in the area of the extraction will be collected non invasively with a collagen sponge to assess the expression of different proteins during the early healing days. On the day of implant placement a sample of bone tissue will also be collected as part of the bone drilling and histologically analysed.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-29.
Trial Details
NCT Number NCT07099846
Lead Sponsor University of Parma
Collaborators: Geistlich Pharma AG
Conditions Socket Preservation, Implant-supported Single Crowns, Hyaluronic Acid, CAD-CAM
Enrollment 40 participants
Start Date 2025-06-09
Primary Completion 2028-03 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2025-09-08