Evaluation of the Performance and Safety of a Linear Hyaluronic Acid-Based Medical Device in the Treatment of Surgical Wounds in the Oral Cavity.

The PR-DENT study is an interventional, single-center, controlled clinical investigation aimed at evaluating the clinical performance and safety of a Class III medical device based on linear hyaluronic acid for the treatment of oral surgical wounds. The investigational device consists of high molecular weight sodium hyaluronate (2500-3500 kDa), obtained through bacterial fermentation, combined with amino acids (L-proline, L-hydroxyproline, glycine, and L-lysine HCl), formulated at a concentration of 25 mg/ml. The device is designed to promote wound healing through the hydrating and film-forming properties of hyaluronic acid, creating a favorable microenvironment for re-epithelialization and tissue regeneration. The study is sponsored by The Wave Innovation Srl and conducted at the Oral Surgery and Stomatology Unit of the Azienda Ospedaliera Universitaria Luigi Vanvitelli, under the scientific responsibility of Prof. Luigi Laino. No additional costs are foreseen for the National Health Service, and no compensation is provided to investigators. The primary objective of the study is to assess the safety and clinical performance of the device in improving the healing of post-surgical oral wounds. The main outcomes include improvement in the Clinical Healing Score (CHS)-a clinical score assessing redness, edema, suppuration, healthy granulation tissue, and signs of re-epithelialization-the rate of wound closure evaluated through morphometric analysis, and the incidence of adverse events. The study population consists of adult patients requiring extraction of at least two teeth. For each patient, two surgical sites are identified: one treated with the hyaluronic acid-based device and one serving as an internal control, allowing for direct intra-patient comparison. The device is injected into the post-extraction socket prior to suturing or applied to the adjacent soft tissues. The study design includes a screening visit (Visit 0), a surgical treatment visit (Visit 1),