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Completed

NCT Number: NCT05536115

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

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 .

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Key information

Conditions

Dry Socket Mouth Diseases Stomatognathic Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Henri-Mondor (AP-HP), Créteil, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alveogyl

Device

The patients will be treated by Alveogyl. Global treatment protocol (curettage, cleaning, local anaesthesia etc.) of the dry socket is at the discretion of the Investigator.

Alveogyl is used as an alveolar dressing. Placement of Alveogyl (about 0.2 g of paste) into the dental socket is done according to its instruction for use by a dental professional only.

Primary outcomes

  1. Pain Using a Visual Analog Scale (VAS : 0-10)

    Time frame: 7 days post-treatment

    Patients with no pain or mild pain at Day7 The pain is measured by patients in a diary using a Visual Analogue Scale (VAS: 0-10 mm; 0 no pain - 10 maximum pain) 7 days after treatment with Alveogyl.

Secondary outcomes

  1. Analgesic Use

    Time frame: 3 and 5 days post-treatment

    Patient reporting a painkiller intake. The patient will report in a diary the intake of analgesic use at 3 and 5 days after treatment with Alveogyl

  2. Healing of the Alveolar Mucosa

    Time frame: 7 days post-treatment

    Healing of the alveolar mucosa will be clinically reported by the dentist using le Wound healing index.

    The Wound Healing Index ranges from 1 (poor healing) to 5 (excellent healing), with higher scores indicating better gingival wound healing.

  3. Signs of Local Inflammation

    Time frame: 7 days post-treatment

    Signs of inflammation around the gingival mucosa (oedema, redness, sensitivity) will be reported by the dentist at Day 7 after tratment with Alveogyl

  4. Antiseptic Effect

    Time frame: 7 days post-treatment

    Any clinical signs such as gum pain, swollen gum lining, fever, halitosis,...) will be reported by the dentist

  5. Hemostasis

    Time frame: Immediately after Alveogyl placement and Day 7 after treatment

    Presence or absence of bleeding in the socket.

  6. Complication Rate

    Time frame: From Alveogyl placement to 7 days post-treatment

    Adverse events occuring within 7 days after treatment

Sponsors and collaborators

Lead sponsor

Septodont

Industry

Collaborators

  • QualityStat
  • SMO Clinical Research

Registry information

Official study title

Prospective, Multicentre Clinical Trial Measuring the Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 10, 2022
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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