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

Study Overview
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Brief Summary
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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 .

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

Conditions
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Dry Socket

Intervention / Treatment
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* Device: Alveogyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study population<br>Study patients are patients with post-extraction dry socket. | Device: Alveogyl<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Healing of the alveolar mucosa | Healing of the alveolar mucosa will be clinically reported by the dentist | 7 days post-treatment | 
| Signs of local inflammation | Signs of inflammation around the gingival mucosa (oedema, redness, sensitivity) will be reported by the dentist | 7 days post-treatment | 
| Antiseptic effect | Any clinical signs such as gum pain, swollen gum lining, fever, halitosis,...) will be reported by the dentist | 7 days post-treatment | 
| Hemostasis | Presence or absence of bleeding in the socket. | Immediately after Alveogyl placement | 
| Complication rate | Adverse events occuring within 7 days after treatment | From Alveogyl placement to 7 days post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tooth extraction, Dry socket, Alveolar Osteitis, Alveogyl, Surgical dressing