Prospective, Multicentre Clinical Trial Measuring the Impact of Treatment withALVEOGYL in Patients with Post-Extraction Dry Socket

ALVE study is a clinical investigation assessing Alveogyl performance and safety in patients with post-extraction dry socket. The study will take place in India and in France where the study device is already marketed. Management of dry socket application protocol is at the discretion of the Investigator. Patients treated with the study device will be screened and eligible patients will be included in the study after obtaining their consent. The primary outcome will be pain assessed by Visual Analog Scale (VAS) for adults at 7 days post-treatment. VAS is a 10-point line from “no pain†(0 points) to “worst imaginable pain†(10 points). A corresponding scale will be used for children as appropriate. Additionally, patients will self-evaluate their pain level, their painkiller use, and the feeling of the Alveogyl (clove) taste on day 3 and day 5 at home. All data will be recorded in an electronic Case Report Form (eCRF) and monitored by the Sponsor’s designee. Self-evaluation by the patients will be recorded on a paper datasheet.