Pain,NCT01603498
Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery
A study testing Dexamethasone and Methylprednisolone in people with Pain, and Edema,, run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
Trial summary
The main aim of the present study was to investigate the effect of preemptive dexamethasone and methylprednisolone to prevent pain, swelling and limitation in mouth opening following third molar extraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Dexamethasone and Methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2011to Dec 2011
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with indication of asymptomatic bilateral extractions of lower third molars
- Aged 18 years or older;
- Have a good health and no disease;
Who cannot join
- Patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Diamantina, Minas Gerais, 39100000
About this study
Official title: Preemptive Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery: a Split-mouth Randomized Triple-blind Clinical Trial
The main aim of the present study was to investigate the effect of preemptive dexamethasone and methylprednisolone to prevent pain, swelling and limitation in mouth opening following third molar extraction.
Read the detailed description
Third molar surgery is often associated with significant post-surgical sequelae. The trauma caused to soft and bony tissue can result in considerable pain, swelling and trismus. Symptoms begin gradually having a peak 2 days after extraction. The use of corticosteroids such as dexamethasone and methylprednisolone can be a valuable tool when performing moderate to moderately severe oral surgical procedures. No clear consensus have emerged yet regarding patient selection, dosage, timing and type of administration of steroid. In this light, this clinical trial aim to compare the effect of preemptive dexamethasone and methylprednisolone to prevent pain, swelling and limitation in mouth opening following third molar extraction.
- Being tested
- Dexamethasone, Methylprednisolone
- Keywords
- pain measurement,, edema,, trismus
- Medical subject headings
- Pain, Edema, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Dexametasone acetate
Dexamethasone 8mg
Methylprednisolone 40mg
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone 8mg | Experimental | Not described Receives: Drug: Dexamethasone |
| Methylprednisolone | Experimental | Methylprednisolone 40mg Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative sequelae following thir molar extraction
During the postoperative intervals of 24, 48 and 72 hours and seven days, the swelling was determined using linear measures in the face and trismus by maximum mouth opening. The postoperative pain was self-recorded by the patient using visual analogue scale in 72 hours with an interval of eight hours
Measured: up to seven days postoperative
Secondary outcomes (1)
Analgesic consumption; duration of surgery
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain,Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and Mucuri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Eduardo Alcântara, MsC, Principal investigator, Federal University of the Valleys of Jequitinhonha and Mucuri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603498
- Sponsor's protocol ID
- 053/10
- Status last verified
- May 2012
- First submitted
- 17 May 2012
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery: a Split-mouth Randomized Triple-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT01603498
- Acronym / sponsor ID
- 053/10
- Keywords
- pain measurement,, edema,, trismus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and MucuriUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 May 2012 (estimated)
- 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.
The main aim of the present study was to investigate the effect of preemptive dexamethasone and methylprednisolone to prevent pain, swelling and limitation in mouth opening following third molar extraction.
Detailed description
Third molar surgery is often associated with significant post-surgical sequelae. The trauma caused to soft and bony tissue can result in considerable pain, swelling and trismus. Symptoms begin gradually having a peak 2 days after extraction. The use of corticosteroids such as dexamethasone and methylprednisolone can be a valuable tool when performing moderate to moderately severe oral surgical procedures. No clear consensus have emerged yet regarding patient selection, dosage, timing and type of administration of steroid. In this light, this clinical trial aim to compare the effect of preemptive dexamethasone and methylprednisolone to prevent pain, swelling and limitation in mouth opening following third molar extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone 8mg | Experimental | Drug: Dexamethasone |
| Methylprednisolone | Experimental | Drug: MethylprednisoloneMethylprednisolone 40mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with indication of asymptomatic bilateral extractions of lower third molars
- Aged 18 years or older;
- Have a good health and no disease;
Key exclusion criteria (1 listed)
- Patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation
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 |
|---|---|---|
| DexamethasoneAlso: Dexametasone acetateDexamethasone 8mg | Drug | Dexamethasone 8mg |
| MethylprednisoloneMethylprednisolone 40mg | Drug | Methylprednisolone |
Primary outcome
Postoperative sequelae following thir molar extraction
Time frame: up to seven days postoperative
During the postoperative intervals of 24, 48 and 72 hours and seven days, the swelling was determined using linear measures in the face and trismus by maximum mouth opening. The postoperative pain was self-recorded by the patient using visual analogue scale in 72 hours with an interval of eight hours
1 secondary outcome
Analgesic consumption; duration of surgery
Time frame: up to 7 days
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 23 May 2012.
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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.
Carlos Eduardo Alcântara, MsC principal investigator
Federal University of the Valleys of Jequitinhonha and Mucuri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and Methylprednisolone in people with Pain, and Edema,, run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
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 3 inclusion and 1 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 23 May 2012. 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 Brazil. 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.
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 sequelae following thir molar extraction (time frame: up to seven days postoperative). 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 23 May 2012.