NCT05536115

Brief 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 .

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
2 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 13, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2025

Completed
8 months until next milestone

Results Posted

Study results publicly available

February 9, 2026

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

September 7, 2022

Results QC Date

January 21, 2026

Last Update Submit

February 10, 2026

Conditions

Dry Socket

Keywords

Tooth extractionDry socketAlveolar OsteitisAlveogylSurgical dressing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Analgesic Use

    3 and 5 days post-treatment

  • Healing of the Alveolar Mucosa

    7 days post-treatment

  • Signs of Local Inflammation

    7 days post-treatment

  • Antiseptic Effect

    7 days post-treatment

  • Hemostasis

    Immediately after Alveogyl placement and Day 7 after treatment

  • +1 more secondary outcomes

Study Arms (1)

Study population

Study patients are patients with post-extraction dry socket.

Device: Alveogyl

Interventions

AlveogylDEVICE

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.

Study population

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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")

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Hospital Henri-Mondor (AP-HP)

Créteil, 94000, France

Location

Odontology Department - Pitié-Salpêtrière Hospital

Paris, 75013, France

Location

Mallige Hospital

Bangalore, Karnataka, 560001, India

Location

Smile Dental Care

Bangalore, Karnataka, 560024, India

Location

Perfect Dental Studio

Bangalore, Karnataka, 560076, India

Location

Cavalier Hospital

Bangalore, Karnataka, 56009443, India

Location

Smile Dental Clinic

Bangalore, Karnataka, 560094, India

Location

The Dental Avenues

Bangalore, Karnataka, 560098, India

Location

Sri Dental Multispeciality Dental Hospital

Hyderabad, 500070, India

Location

Vrisa Dental

Hyderabad, 500079, India

Location

Eledent International Digital Dentistry

Hyderabad, 500085, India

Location

Vardhaman Dental Care

Mumbai, 421203, India

Location

Mayur Dental Clinic

Mumbai, 421501, India

Location

Smile Gallery Dental Care Center

Pune, 411004, India

Location

Dr. Salke Dental & Implant Centre

Pune, 411016, India

Location

Sri Siddhartha Dental College

Tumakuru, 572107, India

Location

MeSH Terms

Conditions

Dry Socket

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Results Point of Contact

Title
Dr. Farid BENABDALLAH
Organization
Septodont
clinical-operations@septodont.com
+33785662179

Study Officials

  • Géraldine Lescaille, DDS, PhD

    Odontology department - Pitié-Salpêtrière Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2022

First Posted

September 10, 2022

Study Start

December 13, 2022

Primary Completion

June 26, 2025

Study Completion

June 26, 2025

Last Updated

March 2, 2026

Results First Posted

February 9, 2026

Record last verified: 2026-02

Locations

FR(2)IN(14)