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

Prospective, Multicentre Clinical Trial Measuring the 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 .

Study Overview

• Status: Completed
• Conditions: Dry Socket
• Intervention / Treatment: Device: Alveogyl

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • Hospital Henri-Mondor (AP-HP)
  • Paris, France, 75013
    • Odontology Department - Pitié-Salpêtrière Hospital
• India
  • Hyderabad, India, 500070
    • Sri Dental Multispeciality Dental Hospital
  • Hyderabad, India, 500079
    • Vrisa Dental
  • Hyderabad, India, 500085
    • Eledent International Digital Dentistry
  • Mumbai, India, 421203
    • Vardhaman Dental Care
  • Mumbai, India, 421501
    • Mayur Dental Clinic
  • Pune, India, 411004
    • Smile Gallery Dental Care Center
  • Pune, India, 411016
    • Dr. Salke Dental & Implant Centre
  • Tumakuru, India, 572107
    • Sri Siddhartha Dental College
  • Karnataka
    • Bangalore, Karnataka, India, 560001
      • Mallige Hospital
    • Bangalore, Karnataka, India, 560024
      • Smile Dental Care
    • Bangalore, Karnataka, India, 560076
      • Perfect Dental Studio
    • Bangalore, Karnataka, India, 56009443
      • Cavalier Hospital
    • Bangalore, Karnataka, India, 560094
      • Smile Dental Clinic
    • Bangalore, Karnataka, India, 560098
      • The Dental Avenues

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with a dry socket occuring after the extraction of a permanent tooth (mature or immature).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study population; Study patients are patients with post-extraction dry socket.	Device: Alveogyl; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Using a Visual Analog Scale (VAS : 0-10)	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.	7 days post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing of the Alveolar Mucosa	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.	7 days post-treatment
Signs of Local Inflammation	Signs of inflammation around the gingival mucosa (oedema, redness, sensitivity) will be reported by the dentist at Day 7 after tratment with Alveogyl	7 days post-treatment
Antiseptic Effect	Any clinical signs such as gum pain, swollen gum lining, fever, halitosis,...) will be reported by the dentist	7 days post-treatment
Hemostasis	Presence or absence of bleeding in the socket.	Immediately after Alveogyl placement and Day 7 after treatment
Complication Rate	Adverse events occuring within 7 days after treatment	From Alveogyl placement to 7 days post-treatment
Analgesic Use	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	3 and 5 days post-treatment

Collaborators and Investigators

• Sponsor: Septodont
• Collaborators: SMO Clinical Research; QualityStat
• Investigators: Study Director: Géraldine Lescaille, DDS, PhD, Odontology Department - Pitié-Salpêtrière Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Actual): June 26, 2025
• Study Completion (Actual): June 26, 2025

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Dry socket; Tooth extraction; Alveolar Osteitis; Alveogyl; Surgical dressing
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Dry Socket
• Other Study ID Numbers: ALVE 2022-01; 2022-A00208-35 (Registry Identifier: ID RCB number (French)); CI/MD/2022/66273 (Registry Identifier: CI MD number (India))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No