Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket

Septodont

Status: Enrolling

Conditions: Dry Socket

Treatments: Device: Alveogyl

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05536115

ALVE 2022-01

CI/MD/2022/66273 (Registry Identifier)

2022-A00208-35 (Registry Identifier)

Details and patient eligibility

About

Alveogyl (Septodont, Saint-Maur-des-Fossés - France) is a Medical Device used as dressing in case of dry socket.

ALVE study is a clinical investigation measuring Alveogyl performance and safety in patients with post-extraction dry socket.

The study takes place in India and in France where Alveogyl is already marketed, since 2010 in France and since 2014 in India .

Enrollment: 120 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patient, adult or child
• Positive diagnosis of dry socket occurring after the extraction of a permanent tooth (mature or immature)
• Signed informed consent
• In France only :Patient affiliated to a Health Insurance Scheme ("sécurité sociale")

Exclusion criteria

• Spreading infection in the alveolar socket
• Placement of Alveogyl done immediately after tooth extraction
• Multiple post-extraction dry sockets
• Patient treated with cervico-facial radiotherapy
• Immunodeficiency related to any diseases or current treatments
• Psychiatric patient or patient unable to assess his/her pain via the study Pain VAS
• Patient with history of hypersensitivity to one of the components
• Patient on post extraction of deciduous teeth
• Participation in another clinical investigation

Trial design

120 participants in 1 patient group

Study population

Description:

Study patients are patients with post-extraction dry socket.

Treatment:

Device: Alveogyl