Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket
- Conditions
- Dry Socket
- Interventions
- Device: Alveogyl
- Registration Number
- NCT05536115
- Lead Sponsor
- Septodont
- 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 .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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")
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study population Alveogyl Study patients are patients with post-extraction dry socket.
- Primary Outcome Measures
Name Time Method Pain using a Visual Analog Scale (VAS : 0-10) 7 days post-treatment 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.
- Secondary Outcome Measures
Name Time Method Healing of the alveolar mucosa 7 days post-treatment Healing of the alveolar mucosa will be clinically reported by the dentist
Signs of local inflammation 7 days post-treatment Signs of inflammation around the gingival mucosa (oedema, redness, sensitivity) will be reported by the dentist
Hemostasis Immediately after Alveogyl placement Presence or absence of bleeding in the socket.
Analgesic use 3, 5 and 7 days post-treatment The patient will report in a diary the intake of analgesic use at 3, 5 and 7 days after treatment with Alveogyl
Antiseptic effect 7 days post-treatment Any clinical signs such as gum pain, swollen gum lining, fever, halitosis,...) will be reported by the dentist
Complication rate From Alveogyl placement to 7 days post-treatment Adverse events occuring within 7 days after treatment
Trial Locations
- Locations (16)
Sri Siddhartha Dental College
🇮🇳Tumkur, India
Odontology Department - Pitié-Salpêtrière Hospital
🇫🇷Paris, France
Smile Dental Clinic
🇮🇳Bangalore, Karnataka, India
Mallige Hospital
🇮🇳Bangalore, Karnataka, India
Hospital Henri-Mondor (AP-HP)
🇫🇷Créteil, France
Perfect Dental Studio
🇮🇳Bangalore, Karnataka, India
Cavalier Hospital
🇮🇳Bangalore, Karnataka, India
Sri Dental Multispeciality Dental Hospital
🇮🇳Hyderabad, India
Vrisa Dental
🇮🇳Hyderabad, India
Smile Gallery Dental Care Center
🇮🇳Pune, India
Dr. Salke Dental & Implant Centre
🇮🇳Pune, India
Smile Dental Care
🇮🇳Bangalore, Karnataka, India
The Dental Avenues
🇮🇳Bangalore, Karnataka, India
Eledent International Digital Dentistry
🇮🇳Hyderabad, India
Vardhaman Dental Care
🇮🇳Mumbai, India
Mayur Dental Clinic
🇮🇳Mumbai, India