Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A00208-35 | Registry Identifier | ID RCB number (French) | |
| CI/MD/2022/66273 | Registry Identifier | CI MD number (India) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| SMO Clinical Research | UNKNOWN |
| QualityStat | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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 .
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study population | Study patients are patients with post-extraction dry socket. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alveogyl | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic Use | 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 | 3 and 5 days post-treatment |
| Healing of the Alveolar Mucosa |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with a dry socket occuring after the extraction of a permanent tooth (mature or immature).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Géraldine Lescaille, DDS, PhD | Odontology department - Pitié-Salpêtrière Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Henri-Mondor (AP-HP) | Créteil | 94000 | France | |||
| Odontology Department - Pitié-Salpêtrière Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Study Population | Study patients are patients with post-extraction dry socket. Alveogyl: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Study Population | Study patients are patients with post-extraction dry socket. Alveogyl: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | PP Population | Posted | Count of Participants | Participants | 7 days post-treatment |
|
7 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Population | Study patients are patients with post-extraction dry socket. Alveogyl: 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Farid BENABDALLAH | Septodont | +33785662179 | clinical-operations@septodont.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2025 | Dec 23, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D004368 | Dry Socket |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
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.
| 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 | 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 and Day 7 after treatment |
| Complication Rate | Adverse events occuring within 7 days after treatment | From Alveogyl placement to 7 days post-treatment |
| Paris |
| 75013 |
| France |
| Mallige Hospital | Bangalore | Karnataka | 560001 | India |
| Smile Dental Care | Bangalore | Karnataka | 560024 | India |
| Perfect Dental Studio | Bangalore | Karnataka | 560076 | India |
| Cavalier Hospital | Bangalore | Karnataka | 56009443 | India |
| Smile Dental Clinic | Bangalore | Karnataka | 560094 | India |
| The Dental Avenues | Bangalore | Karnataka | 560098 | India |
| Sri Dental Multispeciality Dental Hospital | Hyderabad | 500070 | India |
| Vrisa Dental | Hyderabad | 500079 | India |
| Eledent International Digital Dentistry | Hyderabad | 500085 | India |
| Vardhaman Dental Care | Mumbai | 421203 | India |
| Mayur Dental Clinic | Mumbai | 421501 | India |
| Smile Gallery Dental Care Center | Pune | 411004 | India |
| Dr. Salke Dental & Implant Centre | Pune | 411016 | India |
| Sri Siddhartha Dental College | Tumakuru | 572107 | India |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Analgesic Use | 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 | PP population | Posted | Count of Participants | Participants | 3 and 5 days post-treatment |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Wound healing index Score | 7 days post-treatment |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 7 days post-treatment |
|
|
|
| Secondary | Antiseptic Effect | Any clinical signs such as gum pain, swollen gum lining, fever, halitosis,...) will be reported by the dentist | PP population | Posted | Count of Participants | Participants | 7 days post-treatment |
|
|
|
| Secondary | Hemostasis | Presence or absence of bleeding in the socket. | PP population | Posted | Count of Participants | Participants | Immediately after Alveogyl placement and Day 7 after treatment |
|
|
|
| Secondary | Complication Rate | Adverse events occuring within 7 days after treatment | Posted | Count of Participants | Participants | From Alveogyl placement to 7 days post-treatment |
|
|
|
| 0 |
| 120 |
| 0 |
| 120 |
| 0 |
| 120 |
Not provided
Not provided
|
| Patient not reporting a painkiller intake |
|
| Fever |
|
| Tenderness of the gingival mucosa |
|
| Purulent collection in the alveolus and gingival mucosa |
|
| Pale discoloration of the dry socket |
|
| Patients showing hemorrhagic oozing |
|
| Presence or absence of bleeding in the socket 7 days after Alveogyl placement |
|