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

Dry Socket Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05536115
• Other study ID #: ALVE 2022-01
• Secondary ID: 2022-A00208-35CI
• Status: Recruiting
• Start date: December 13, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Septodont
• Contact: Farid BENABDALLAH, MD
• Phone: +33 (0)7 85 66 21 79
• Email: fbenabdallah[@]septodont.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Socket

Intervention

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.

Locations

Country	Name	City	State
France	Hospital Henri-Mondor (AP-HP)	Créteil
France	Odontology Department - Pitié-Salpêtrière Hospital	Paris
India	Cavalier Hospital	Bangalore	Karnataka
India	Mallige Hospital	Bangalore	Karnataka
India	Perfect Dental Studio	Bangalore	Karnataka
India	Smile Dental Care	Bangalore	Karnataka
India	Smile Dental Clinic	Bangalore	Karnataka
India	The Dental Avenues	Bangalore	Karnataka
India	Eledent International Digital Dentistry	Hyderabad
India	Sri Dental Multispeciality Dental Hospital	Hyderabad
India	Vrisa Dental	Hyderabad
India	Mayur Dental Clinic	Mumbai
India	Vardhaman Dental Care	Mumbai
India	Dr. Salke Dental & Implant Centre	Pune
India	Smile Gallery Dental Care Center	Pune
India	Sri Siddhartha Dental College	Tumkur

Sponsors (3)

Lead Sponsor	Collaborator
Septodont	QualityStat, SMO Clinical Research

Countries where clinical trial is conducted

France,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain using a Visual Analog Scale (VAS : 0-10)	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	Analgesic use	The patient will report in a diary the intake of analgesic use at 3, 5 and 7 days after treatment with Alveogyl	3, 5 and 7 days post-treatment
Secondary	Healing of the alveolar mucosa	Healing of the alveolar mucosa will be clinically reported by the dentist	7 days post-treatment
Secondary	Signs of local inflammation	Signs of inflammation around the gingival mucosa (oedema, redness, sensitivity) will be reported by the dentist	7 days post-treatment
Secondary	Antiseptic effect	Any clinical signs such as gum pain, swollen gum lining, fever, halitosis,...) will be reported by the dentist	7 days post-treatment
Secondary	Hemostasis	Presence or absence of bleeding in the socket.	Immediately after Alveogyl placement
Secondary	Complication rate	Adverse events occuring within 7 days after treatment	From Alveogyl placement to 7 days post-treatment