Overview
Sponsor-declared trial summary
Third molar extraction
It is planned to evaluate the effectiveness of dexamethasone applied orally, in compared to intramuscular application in the masseter muscle, in both cases immediately before starting the surgical procedure.
Key facts
- Sponsor
- Complutense University Of Madrid
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Disorders of Environmental Origin [C21], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Decision date (initial)
- 2025-03-14
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response
It is planned to evaluate the effectiveness of dexamethasone applied orally, in compared to intramuscular application in the masseter muscle, in both cases
immediately before starting the surgical procedure.
Conditions and MedDRA coding
Third molar extraction
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Reclutamiento Muestras
|
Randomised Controlled | None | [{"id":110840,"code":1,"name":"Subject"},{"id":110839,"code":2,"name":"Investigator"}] |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Present both lower molars in conditions of intraosseous retention
- Male or female sex
- Age between 18 and 40 years
- Sign informed consent to participate in the study.
- Retention of lower molars in similar position and angulation.
- Systemic status compatible with ASA I classification.
- Not having received any anti-inflammatory treatment for at least 30 days before the surgery.
Exclusion criteria 8
- Pregnant or breastfeeding patients
- Patients who refuse to sign the informed consent
- Smoking
- Diagnosis of severe periodontal disease
- Presence of any oral pathology that contraindicates the performance of Surgery.
- Established diagnosis of any of the following diseases or conditions: o Diabetes mellitus o HIV infection o Active hepatitis B or C o Bone metabolism diseases o Autoimmune diseases
- Patients allergic to paracetamol
- Patients allergic to beta-lactam antibiotics
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- One year follow-up
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- DENTAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- LOCAL INJECTION
- Max daily dose
- 12 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Complutense University Of Madrid
- Sponsor organisation
- Complutense University Of Madrid
- Address
- Plaza De Ramon Y Cajal S/N
- City
- Madrid
- Postcode
- 28040
- Country
- Spain
Scientific contact point
- Organisation
- Complutense University Of Madrid
- Contact name
- Carlos
Public contact point
- Organisation
- Complutense University Of Madrid
- Contact name
- Carlos
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 3 | 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 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol 2024-517000-11-00-IN-001 copia | 4 |
| Protocol (for publication) | Protocol 2024-517000-11-00-IN-001 copia v5 | 5 |
| Protocol (for publication) | Protocolo 2024-517000-11-00-IN-001 | 4 |
| Protocol (for publication) | Protocolo 2024-517000-11-00-IN-001 copia v5 | 5 |
| Recruitment arrangements (for publication) | Consentimiento e Informacion | 2 |
| Subject information and informed consent form (for publication) | Consentimiento e Informacion | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | Product suitability inyectable 2024-517000-11-00IN-001 | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | Product suitability oral 2024-517000-11-00IN-001 | 3 |
| Synopsis of the protocol (for publication) | Protocol sinopsis 2024-517000-11-00-IN-001 | 2 |
| Synopsis of the protocol (for publication) | Protocol sinopsis English 2024-517000-11-00-IN-001 | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-25 | Spain | Acceptable 2025-03-14
|
2025-03-14 |