Treatment with ALVEOGYL, an alveolar dressing used in patients with a dry socket occurring after tooth extractio
Phase 4
Completed
- Conditions
- Health Condition 1: M273- Alveolitis of jaws
- Registration Number
- CTRI/2023/03/050706
- Lead Sponsor
- SEPTODONT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
1. Male or female patient, adult or child
2. Positive diagnosis of dry socket occurring after the extraction
of a permanent tooth (mature or immature)
3. Signed informed consent
Exclusion Criteria
1. Spreading infection in the alveolar socket
2. Placement of Alveogyl done immediately after tooth extraction
3. Multiple post-extraction dry sockets
4. Patient treated with cervicofacial radiotherapy
5. Immunodeficiency related to any diseases or current treatments
6. Psychiatric patient
7. Patient with a history of hypersensitivity to one of the
components
8. Patient on post-extraction of deciduous teeth
9. Participation in another clinical investigation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain Visual Analog Scale (VAS) at 7 days post-treatmentTimepoint: 8 Days
- Secondary Outcome Measures
Name Time Method 1. Painkiller intake: Analgesic use [Time Frame: at 3 days, 5 days <br/ ><br>and 7 days post-treatment] <br/ ><br>2. Healing: Evaluation of healing of the alveolar mucosa. [Time <br/ ><br>Frame: at 7days post-treatment]. <br/ ><br>3. Local inflammation: Signs of inflammation around the gingival <br/ ><br>mucosa (oedema, redness, sensitivity) [Time Frame: at 7 days <br/ ><br>posttreatment]. <br/ ><br>4. Antiseptic effect: Clinical signs (e.g., gum pain, swollen gum <br/ ><br>lining, fever, halitosis). [Time Frame: at 7 days post-treatment]. <br/ ><br>5. Haemostasis: presence or absence of bleeding [Time Frame: <br/ ><br>after Alveogyl placement]. <br/ ><br>6. Safety: Complication rate [Time Frame: From Alveogyl <br/ ><br>placement to 7days post-treatment]Timepoint: 8 Days