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

Last updated: November 28, 2023
Sponsor: Septodont
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Alveogyl

Clinical Study ID

NCT05536115
ALVE 2022-01
CI/MD/2022/66273
2022-A00208-35
  • Ages > 5
  • All Genders

Study Summary

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 .

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Alveogyl
Phase:
Study Start date:
December 13, 2022
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Hospital Henri-Mondor (AP-HP)

    Créteil, 94000
    France

    Active - Recruiting

  • Odontology Department - Pitié-Salpêtrière Hospital

    Paris, 75013
    France

    Active - Recruiting

  • Cavalier Hospital

    Bangalore, Karnataka 56009443
    India

    Completed

  • Mallige Hospital

    Bangalore, Karnataka 560001
    India

    Completed

  • Perfect Dental Studio

    Bangalore, Karnataka 560076
    India

    Completed

  • Smile Dental Care

    Bangalore, Karnataka 560024
    India

    Completed

  • Smile Dental Clinic

    Bangalore, Karnataka 560094
    India

    Completed

  • The Dental Avenues

    Bangalore, Karnataka 560098
    India

    Completed

  • Eledent International Digital Dentistry

    Hyderabad, 500085
    India

    Completed

  • Sri Dental Multispeciality Dental Hospital

    Hyderabad, 500070
    India

    Completed

  • Vrisa Dental

    Hyderabad, 500079
    India

    Completed

  • Mayur Dental Clinic

    Mumbai, 421501
    India

    Completed

  • Vardhaman Dental Care

    Mumbai, 421203
    India

    Completed

  • Dr. Salke Dental & Implant Centre

    Pune, 411016
    India

    Completed

  • Smile Gallery Dental Care Center

    Pune, 411004
    India

    Completed

  • Sri Siddhartha Dental College

    Tumkur, 572107
    India

    Completed

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