Clinical trial • Not applicable • Other
DEXAMETHASONE for Impacted/retained lower third molar
Not applicable trial of DEXAMETHASONE for Impacted/retained lower third molar.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Impacted/retained lower third molar
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 25-11-2024
- First CTIS Authorization Date
- 14-03-2025
Trial design
Randomised, test: dexamethasone (oral solution); max daily dose 10 mg; max total 40 mg; route: dental use. comparator: dexamethasone (solution for injection); max daily dose 12 mg; max total 50 mg; route: local injection.-controlled Not applicable trial across 1 site in Spain.
- Randomised
- Yes
- Comparator
- Test: DEXAMETHASONE (oral solution); max daily dose 10 mg; max total 40 mg; route: dental use. Comparator: DEXAMETHASONE (solution for injection); max daily dose 12 mg; max total 50 mg; route: local injection.
- Target Sample Size
- 3
- Trial Duration For Participant
- 365
Eligibility
Recruits 3 Vulnerable population not selected (isVulnerablePopulationSelected: false). Participants must sign informed consent; no assent procedures or special vulnerable-population consent arrangements are described..
- Pregnancy Exclusion
- Pregnant or breastfeeding patients
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected: false). Participants must sign informed consent; no assent procedures or special vulnerable-population consent arrangements are described.
Inclusion criteria
- {"criterion_text":"- Present both lower molars in conditions of intraosseous retention\n- Male or female sex\n- Age between 18 and 40 years\n- Sign informed consent to participate in the study.\n- Retention of lower molars in similar position and angulation.\n- Systemic status compatible with ASA I classification.\n- Not having received any anti-inflammatory treatment for at least 30 days before the surgery."}
Exclusion criteria
- {"criterion_text":"- Pregnant or breastfeeding patients\n- Patients who refuse to sign the informed consent\n- Smoking\n- Diagnosis of severe periodontal disease\n- Presence of any oral pathology that contraindicates the performance of Surgery.\n- 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\n- Patients allergic to paracetamol\n- Patients allergic to beta-lactam antibiotics"}
Endpoints
Primary endpoints
- {"endpoint_text":"- One year follow-up","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 3
- Recruitment Window Months
- 7
- Consent Approach
- Participants (adults) must sign informed consent to participate in the study (criterion: 'Sign informed consent to participate in the study.'). Subject information and informed consent form documents are provided (document titles include 'Consentimiento e Informacion'). No assent or additional age-specific consent procedures are described; vulnerable population not selected.
Methods
- Those patients who meet the eligibility criteria will be invited consecutively. inclusion previously mentioned who attend the Postgraduate Specialization in Oral Surgery and Implantology of the Faculty of Dentistry of the University Complutense of Madrid for two academic years.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 3
Spain
- Earliest CTIS Part Ii Submission Date
- 20-02-2025
- Latest Decision Or Authorization Date
- 14-03-2025
- Processing Time Days
- 22
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Complutense University Of Madrid
- Department Name
- Departament of Clinical Specialities
- Contact Person Name
- Carlos Manuel Cobo Vazquez
- Contact Person Email
- cmcobo@ucm.es
- Number Of Participants
- 3
Sponsor
Primary sponsor
- Full Name
- Complutense University Of Madrid
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- DEXAMETHASONE (oral solution)
- Active Substance
- DEXAMETHASONE
- Modality
- Small molecule
- Routes Of Administration
- DENTAL USE
- Route
- DENTAL USE
- Maximum Dose
- max daily 10 mg; max total 40 mg
- Investigational Product Name
- DEXAMETHASONE (solution for injection)
- Active Substance
- DEXAMETHASONE
- Modality
- Small molecule
- Routes Of Administration
- LOCAL INJECTION
- Route
- LOCAL INJECTION
- Maximum Dose
- max daily 12 mg; max total 50 mg
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