Clinical trial NCT05536115: Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket
Official title: Prospective, Multicentre Clinical Trial Measuring the Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dry Socket
Keywords: Tooth extraction
Dry socket
Alveolar Osteitis
Alveogyl
Surgical dressing
Lead sponsor: Septodont
Sponsor class: INDUSTRY
Collaborators: name: SMO Clinical Research
name: QualityStat
First posted: 2022-09-10
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a dry socket occuring after the extraction of a permanent tooth (mature or immature).

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 .


Eligibility 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

Primary outcomes:
measure: Pain using a Visual Analog Scale (VAS : 0-10)
timeFrame: 7 days post-treatment
Secondary outcomes:
measure: Analgesic use
timeFrame: 3, 5 and 7 days post-treatment
measure: Healing of the alveolar mucosa
timeFrame: 7 days post-treatment
measure: Signs of local inflammation
timeFrame: 7 days post-treatment
measure: Antiseptic effect
timeFrame: 7 days post-treatment
measure: Hemostasis
timeFrame: Immediately after Alveogyl placement
measure: Complication rate
timeFrame: From Alveogyl placement to 7 days post-treatment
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hospital Henri-Mondor (AP-HP)
city: Paris
country: France
facility: Odontology Department - Pitié-Salpêtrière Hospital
city: Bangalore
country: India
facility: Mallige Hospital
state: Karnataka
city: Bangalore
country: India
facility: Smile Dental Care
state: Karnataka
city: Bangalore
country: India
facility: Perfect Dental Studio
state: Karnataka
city: Bangalore
country: India
facility: Cavalier Hospital
state: Karnataka
city: Bangalore
country: India
facility: Smile Dental Clinic
state: Karnataka
city: Bangalore
country: India
facility: The Dental Avenues
state: Karnataka
city: Hyderabad
country: India
facility: Sri Dental Multispeciality Dental Hospital
city: Hyderabad
country: India
facility: Vrisa Dental
city: Hyderabad
country: India
facility: Eledent International Digital Dentistry
city: Mumbai
country: India
facility: Vardhaman Dental Care
city: Mumbai
country: India
facility: Mayur Dental Clinic
city: Pune
country: India
facility: Smile Gallery Dental Care Center
city: Pune
country: India
facility: Dr. Salke Dental & Implant Centre
city: Tumkur
country: India
facility: Sri Siddhartha Dental College
Study officials:
affiliation: Odontology department - Pitié-Salpêtrière Hospital
name: Géraldine Lescaille, DDS, PhD
role: STUDY_DIRECTOR
References: