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

Septodont120 enrolled

Overview

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 .

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Dry Socket

Interventions

AlveogylDEVICE

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.

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

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

Locations (16)

Hospital Henri-Mondor (AP-HP)

Créteil, France

Odontology Department - Pitié-Salpêtrière Hospital

Paris, France

Mallige Hospital

Bangalore, Karnataka, India

Outcomes

Primary Outcomes

Pain Using a Visual Analog Scale (VAS : 0-10)

Patients with no pain or mild pain at Day7 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.

Time frame: 7 days post-treatment

Secondary Outcomes

Analgesic Use

Patient reporting a painkiller intake. The patient will report in a diary the intake of analgesic use at 3, 5 and 7 days after treatment with Alveogyl

Time frame: 3 and 5 days post-treatment

Healing of the Alveolar Mucosa

Healing of the alveolar mucosa will be clinically reported by the dentist using le Wound healing index. The Wound Healing Index ranges from 1 (poor healing) to 5 (excellent healing), with higher scores indicating better gingival wound healing.

Time frame: 7 days post-treatment

Signs of Local Inflammation

Signs of inflammation around the gingival mucosa (oedema, redness, sensitivity) will be reported by the dentist at Day 7 after tratment with Alveogyl

Time frame: 7 days post-treatment

Antiseptic Effect

Any clinical signs such as gum pain, swollen gum lining, fever, halitosis,...) will be reported by the dentist

Time frame: 7 days post-treatment

Hemostasis

Presence or absence of bleeding in the socket.

Time frame: Immediately after Alveogyl placement and Day 7 after treatment

Complication Rate

Adverse events occuring within 7 days after treatment

Data from ClinicalTrials.gov

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