Clinical trial • Not applicable • Other
METHYLPREDNISOLONE HEMISUCCINATE for Postoperative sequelae
Not applicable trial of METHYLPREDNISOLONE HEMISUCCINATE for Postoperative sequelae.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Postoperative sequelae
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 08-01-2025
- First CTIS Authorization Date
- 15-01-2025
Trial design
Randomised, intervention: solu-medrol (methylprednisolone hemisuccinate) preoperative intramasseteric/intramuscular injection (dose/schedule not specified); comparator: placebo (dose and schedule not specified)-controlled Not applicable trial across 1 site in Hungary.
- Randomised
- Yes
- Comparator
- Intervention: SOLU-MEDROL (methylprednisolone hemisuccinate) preoperative intramasseteric/intramuscular injection (dose/schedule not specified); Comparator: Placebo (dose and schedule not specified)
- Target Sample Size
- 30
Eligibility
Recruits 30 adults.
Inclusion criteria
- {"criterion_text":"- on both sides existing lower wisdom teeth, in deeper impaction and similar position\n- between the age of 18 and 50\n- healthy\n- not receiving any medication that can affect the treatment\n- good oral hygiene"}
Exclusion criteria
- {"criterion_text":"- smoking\n- poor oral hygiene\n- receiving medication that can affect the treatment\n- disease or general state that can affect the treatment\n- symptoms of inflammation in the surgical area\n- if the patient can not appear on the control examinations"}
Endpoints
Primary endpoints
- {"endpoint_text":"- -","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 23
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 30
Hungary
- Earliest CTIS Part Ii Submission Date
- 08-01-2025
- Latest Decision Or Authorization Date
- 15-01-2025
- Processing Time Days
- 7
- Number Of Sites
- 1
- Number Of Participants
- 30
Sites
- Site Name
- Semmelweis University
- Department Name
- Oro-Maxillofacial Surgery
- Contact Person Name
- Árpád Joób-Fancsaly
- Contact Person Email
- titkarsag.arcallcsont@semmelweis.hu
- Number Of Participants
- 30
Sponsor
Primary sponsor
- Full Name
- Semmelweis University
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Hungary
Investigational products
- Investigational Product Name
- SOLU-MEDROL 40 mg/1 mL, poudre et solvant pour solution injectable
- Active Substance
- METHYLPREDNISOLONE HEMISUCCINATE
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INJECTION
- Route
- SOLUTION FOR INJECTION
- Authorisation Status
- Authorised (marketing authorisation available; authorisation country: FR)
- Maximum Dose
- 1000 mg
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