Stopped: We agreed with the sponsor that the recruitment of 28 subjects would already be sufficient to obtain statistically significant results. For this reason, we submitted an amendment to the Ethics Committee.
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), and three follow-up visits at 7, 14, and 30 days after treatment completion (Visits 2, 3, and 4). During follow-up visits, the Clinical Healing Score, wound closure via morphometric analysis, and the occurrence of any adverse events are assessed. Inclusion criteria include adult patients in good systemic and oral health, able to comply with study procedures, and who have provided written informed consent. Exclusion criteria include factors that may interfere with wound healing, such as smoking more than 10 cigarettes per day, recent oncological therapies, recent antibiotic therapy, bisphosphonate treatment, pregnancy or breastfeeding, and acute infection at the surgical site. Safety is evaluated through the recording and classification of all adverse events (AEs) and serious adverse events (SAEs), in accordance with applicable regulations and Good Clinical Practice (ISO 14155). Risks associated with the use of the device are considered minimal and mainly related to the surgical procedure itself. Based on extensive scientific literature supporting the use of hyaluronic acid in oral wound healing, the overall risk-benefit profile is considered favorable. The study is conducted in compliance with the principles of the Declaration of Helsinki, Good Clinical Practice, and Regulation (EU) 2017/745 on medical devices.
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Improvement in Clinical Healing Score (CHS)
Timeframe: 7 days after the surgical treatment (Visit 2).