Overview
Sponsor-declared trial summary
postoperative sequalae
To investigate the effect of intramuscular corticosteroid injection on the post-operative swelling, trismus and pain following lower third molar surgery
Key facts
- Sponsor
- Semmelweis University
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Decision date (initial)
- 2025-01-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520422-11-00
- EudraCT number
- 2018-004083-62
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Prophylaxis
To investigate the effect of intramuscular corticosteroid injection on the post-operative
swelling, trismus and pain following lower third molar surgery
Conditions and MedDRA coding
postoperative sequalae
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- on both sides existing lower wisdom teeth, in deeper impaction and similar position; between the age of 18 and 50; healthy; not receiving any medication that can affect the treatment; good oral hygiene
Exclusion criteria 1
- smoking; poor oral hygiene; receiving medication that can affect the treatment; disease or general state that can affect the treatment; symptoms of inflammation in the surgical area; if the patient can not appear on the control examinations
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- -
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SOLU-MEDROL 40 mg/1 mL, poudre et solvant pour solution injectable
PRD10932440 · Product
- Active substance
- Methylprednisolone Hemisuccinate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB04 — METHYLPREDNISOLONE
- Marketing authorisation
- 34009 302 814 6 8
- MA holder
- PFIZER HOLDING FRANCE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Semmelweis University
- Sponsor organisation
- Semmelweis University
- Address
- Maria Utca 52
- City
- Budapest
- Postcode
- 1085
- Country
- Hungary
Scientific contact point
- Organisation
- Semmelweis University
- Contact name
- Dr. Dorottya Kiss
Public contact point
- Organisation
- Semmelweis University
- Contact name
- Dr. Dorottya Kiss
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Authorised, recruitment pending | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol | 1 |
| Recruitment arrangements (for publication) | recruitment | 1 |
| Subject information and informed consent form (for publication) | consent | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | methylprednisolone sodium succinate - Solu-Medrol | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-08 | Hungary | Acceptable 2025-01-15
|
2025-01-15 |