Treatment with Alveogyl for dry socket after tooth extraction
Prospective, Multicentre Clinical Trial Measuring the Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket
This study is testing if Alveogyl can help both adults and children feel better after getting a dry socket from a tooth extraction.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Septodont Industry-sponsored |
| Locations | 16 sites (Créteil and 15 other locations) |
| Trial ID | NCT05536115 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates the performance and safety of Alveogyl, a medical device used as a dressing for patients suffering from post-extraction dry socket. The study includes both adult and child patients diagnosed with dry socket following the extraction of a permanent tooth. It is conducted in India and France, where Alveogyl has been marketed since 2010 and 2014, respectively. Participants must provide informed consent and meet specific inclusion criteria while being excluded if they have certain medical conditions or treatments.
Who should consider this trial
Good fit: Ideal candidates include adults and children diagnosed with dry socket after the extraction of a permanent tooth.
Not a fit: Patients with spreading infections in the alveolar socket or those who have multiple post-extraction dry sockets may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate pain and promote healing in patients suffering from dry socket.
How similar studies have performed: Previous studies have shown positive outcomes with similar treatments for dry socket, indicating potential for success in this investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Créteil and 15 other locations
- Hospital Henri-Mondor (AP-HP) — Créteil, France (Recruiting)
- Odontology Department - Pitié-Salpêtrière Hospital — Paris, France (Recruiting)
- Mallige Hospital — Bangalore, Karnataka, India (Completed)
- Smile Dental Care — Bangalore, Karnataka, India (Completed)
- Perfect Dental Studio — Bangalore, Karnataka, India (Completed)
- Cavalier Hospital — Bangalore, Karnataka, India (Completed)
- Smile Dental Clinic — Bangalore, Karnataka, India (Completed)
- The Dental Avenues — Bangalore, Karnataka, India (Completed)
- Sri Dental Multispeciality Dental Hospital — Hyderabad, India (Completed)
- Vrisa Dental — Hyderabad, India (Completed)
- Eledent International Digital Dentistry — Hyderabad, India (Completed)
- Vardhaman Dental Care — Mumbai, India (Completed)
- Mayur Dental Clinic — Mumbai, India (Completed)
- Smile Gallery Dental Care Center — Pune, India (Completed)
- Dr. Salke Dental & Implant Centre — Pune, India (Completed)
- Sri Siddhartha Dental College — Tumkur, India (Completed)
Study contacts
- Study coordinator: Farid BENABDALLAH, MD
- Email: fbenabdallah@septodont.com
- Phone: +33 (0)7 85 66 21 79
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.