Dry Socket
Conditions
Keywords
Tooth extraction, Dry socket, Alveolar Osteitis, Alveogyl, Surgical dressing
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 .
Interventions
DEVICEAlveogyl
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.
Sponsors
Septodont
SMO Clinical Research
QualityStat
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Using a Visual Analog Scale (VAS : 0-10) | 7 days post-treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic Use | 3 and 5 days post-treatment | Patient reporting a painkiller intake. The patient will report in a diary the intake of analgesic use at 3 and 5 days after treatment with Alveogyl |
| Healing of the Alveolar Mucosa | 7 days post-treatment | 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. |
| Signs of Local Inflammation | 7 days post-treatment | Signs of inflammation around the gingival mucosa (oedema, redness, sensitivity) will be reported by the dentist at Day 7 after tratment 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 |
| Hemostasis | Immediately after Alveogyl placement and Day 7 after treatment | Presence or absence of bleeding in the socket. |
| Complication Rate | From Alveogyl placement to 7 days post-treatment | Adverse events occuring within 7 days after treatment |
Countries
France, India
Contacts
STUDY_DIRECTORGéraldine Lescaille, DDS, PhD
Odontology department - Pitié-Salpêtrière Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 42.6 years STANDARD_DEVIATION 15.2 |
| Region of Enrollment France | 30 participants |
| Region of Enrollment India | 90 participants |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 120 |
| other Total, other adverse events | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 |
Outcome results
None listed