InflammationPhase 2/3NCT05752305
Use of Corticosteroids in Third Molar Surgery
A Phase 2/3 study testing Dexamethasone 4 Mg/mL Injectable Solution and MethylPREDNISolone 40 Mg/mL Injectable Suspension in people with Inflammation and Pain, Postoperative, run by Universidad de Granada at 1 site in Spain.
Trial summary
Surgical extraction of retained lower third molars is associated with the development of postoperative complications, including inflammation, trismus and postoperative pain, that lead to a decrease in patients' quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Pain, Postoperative, Trismus
- What is being tested?
- Dexamethasone 4 Mg/mL Injectable Solution and MethylPREDNISolone 40 Mg/mL Injectable Suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2022to 15 Jul 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age
- Indication for surgical extraction of a retained lower third molar
Who cannot join
- Patients treated with corticosteroids in the last 3 months
- Patients treated with NSAIDs in the last 7 days
- Patients with hypersensitivity to the drug
- Patients with a medical condition that contraindicates the administration of the drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Administration of Dexamethasone Versus Methylprednisolone in Surgical Extraction of Retained Lower Third Molars
Surgical extraction of retained lower third molars is associated with the development of postoperative complications, including inflammation, trismus and postoperative pain, that lead to a decrease in patients' quality of life. Therefore, the use of drugs is essential to reduce the morbidity associated with surgery, with NSAIDs and corticosteroids being the most commonly used drugs.
Read the detailed description
Surgical extraction of retained lower third molars is associated with the development of postoperative complications, including inflammation, trismus and postoperative pain. Traditionally, NSAIDs have been used for the treatment of postoperative pain and inflammation, although corticosteroids are increasingly used in oral surgery, as they have proven to be clinically effective in reducing postoperative complications without causing serious adverse effects. Although numerous studies have been carried out comparing different corticosteroids in order to determine which of them is the most effective, there is still no clinical protocol regulating the use of these drugs in oral surgery. Therefore, this clinical trial is based on comparing two of the most studied corticosteroids used in oral surgery to date: dexamethasone and methylprednisolone.
This study is based on the preoperative administration of 8mg of dexamethasone or 40mg of methylprednisolone via submucosa, randomly, in patients undergoing surgical extraction of a retained lower third molar, to determine which of these two drugs is more effective in the prevention of inflammation, trismus and postoperative pain.
- Conditions
- Inflammation, Pain, Postoperative, Trismus
- Being tested
- Dexamethasone 4 Mg/mL Injectable Solution, MethylPREDNISolone 40 Mg/mL Injectable Suspension
- Medical subject headings
- Inflammation, Pain, Postoperative, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 4 Mg/mL Injectable SolutionDrug
Preoperative submucosal administration of 8mg of dexamethasone or 40mg of methylprednisolone.
MethylPREDNISolone 40 Mg/mL Injectable SuspensionDrug
Preoperative submucosal administration of 8mg of dexamethasone or 40mg of methylprednisolone.
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone group | Experimental | Preoperative administration of 40mg of methylprednisolone via submucosa Receives: Drug: MethylPREDNISolone 40 Mg/mL Injectable Suspension |
| Dexamethasone group | Experimental | Preoperative administration of 8mg of dexamethasone via submucosa Receives: Drug: Dexamethasone 4 Mg/mL Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative inflammation following third molar surgical extraction
Postoperative swelling was determined by measuring tragus-chin distance, tragus-labial cleft distance and eye angle-jaw angle distance, using a millimeter ruler.
Measured: 7 days
Postoperative trismus following third molar surgical extraction
Postoperative trismus was assessed by measuring the patient's maximum mouth opening (measuring the distance between the incisal edge of the upper central incisor and the lower central incisor) using a millimeter ruler.
Measured: 7 days
Postoperative pain following third molar surgical extraction
Postoperative pain was measured using the Visual Analogue Scale (VAS): patients were asked to assign a numerical value from 0-100 (0 being no pain and 100 the maximum pain).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start15 Jan 2022
- Primary completion1 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Unai Fernández Martín, Universidad de Granada
- Investigators
- Unai Fernández, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752305
- Sponsor's protocol ID
- 3180/CEIH/2023
- Status last verified
- Nov 2023
- First submitted
- 9 Feb 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Administration of Dexamethasone Versus Methylprednisolone in Surgical Extraction of Retained Lower Third Molars
- ClinicalTrials.gov ID
- NCT05752305
- Acronym / sponsor ID
- 3180/CEIH/2023
- Conditions
- Inflammation, Pain, Postoperative, Trismus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surgical extraction of retained lower third molars is associated with the development of postoperative complications, including inflammation, trismus and postoperative pain, that lead to a decrease in patients' quality of life. Therefore, the use of drugs is essential to reduce the morbidity associated with surgery, with NSAIDs and corticosteroids being the most commonly used drugs.
Detailed description
Surgical extraction of retained lower third molars is associated with the development of postoperative complications, including inflammation, trismus and postoperative pain. Traditionally, NSAIDs have been used for the treatment of postoperative pain and inflammation, although corticosteroids are increasingly used in oral surgery, as they have proven to be clinically effective in reducing postoperative complications without causing serious adverse effects. Although numerous studies have been carried out comparing different corticosteroids in order to determine which of them is the most effective, there is still no clinical protocol regulating the use of these drugs in oral surgery. Therefore, this clinical trial is based on comparing two of the most studied corticosteroids used in oral surgery to date: dexamethasone and methylprednisolone.
This study is based on the preoperative administration of 8mg of dexamethasone or 40mg of methylprednisolone via submucosa, randomly, in patients undergoing surgical extraction of a retained lower third molar, to determine which of these two drugs is more effective in the prevention of inflammation, trismus and postoperative pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone group | Experimental | Drug: MethylPREDNISolone 40 Mg/mL Injectable SuspensionPreoperative administration of 40mg of methylprednisolone via submucosa |
| Dexamethasone group | Experimental | Drug: Dexamethasone 4 Mg/mL Injectable SolutionPreoperative administration of 8mg of dexamethasone via submucosa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years of age
- Indication for surgical extraction of a retained lower third molar
Key exclusion criteria (4 listed)
- Patients treated with corticosteroids in the last 3 months
- Patients treated with NSAIDs in the last 7 days
- Patients with hypersensitivity to the drug
- Patients with a medical condition that contraindicates the administration of the drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone 4 Mg/mL Injectable SolutionPreoperative submucosal administration of 8mg of dexamethasone or 40mg of methylprednisolone. | Drug | Dexamethasone group |
| MethylPREDNISolone 40 Mg/mL Injectable SuspensionPreoperative submucosal administration of 8mg of dexamethasone or 40mg of methylprednisolone. | Drug | Methylprednisolone group |
Primary outcome
Postoperative inflammation following third molar surgical extraction
Time frame: 7 days
Postoperative swelling was determined by measuring tragus-chin distance, tragus-labial cleft distance and eye angle-jaw angle distance, using a millimeter ruler.
Postoperative trismus following third molar surgical extraction
Time frame: 7 days
Postoperative trismus was assessed by measuring the patient's maximum mouth opening (measuring the distance between the incisal edge of the upper central incisor and the lower central incisor) using a millimeter ruler.
Postoperative pain following third molar surgical extraction
Time frame: 7 days
Postoperative pain was measured using the Visual Analogue Scale (VAS): patients were asked to assign a numerical value from 0-100 (0 being no pain and 100 the maximum pain).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Unai Fernández principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexamethasone 4 Mg/mL Injectable Solution and MethylPREDNISolone 40 Mg/mL Injectable Suspension in people with Inflammation and Pain, Postoperative, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative inflammation following third molar surgical extraction (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.