Back to resultsEffect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery
Primary Purpose
Pain,, Edema,, Trismus
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dexamethasone
Methylprednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Pain, focused on measuring pain measurement,, edema,, trismus
Eligibility Criteria
Inclusion Criteria:
- Patients with indication of asymptomatic bilateral extractions of lower third molars
- Aged 18 years or older;
- Have a good health and no disease;
Exclusion Criteria:
- 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
Sites / Locations
- Universidade Federal dos Vales do Jequitinhonha e Mucuri
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dexamethasone 8mg
Methylprednisolone
Arm Description
Methylprednisolone 40mg
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Analgesic consumption; duration of surgery
Full Information
NCT ID
NCT01603498
First Posted
May 17, 2012
Last Updated
May 21, 2012
Sponsor
Federal University of the Valleys of Jequitinhonha and Mucuri
1. Study Identification
Unique Protocol Identification Number
NCT01603498
Brief Title
Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal University of the Valleys of Jequitinhonha and Mucuri
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain,, Edema,, Trismus
Keywords
pain measurement,, edema,, trismus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone 8mg
Arm Type
Experimental
Arm Title
Methylprednisolone
Arm Type
Experimental
Arm Description
Methylprednisolone 40mg
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Dexametasone acetate
Intervention Description
Dexamethasone 8mg
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
Methylprednisolone 40mg
Primary Outcome Measure Information:
Title
Postoperative sequelae following thir molar extraction
Description
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
Time Frame
up to seven days postoperative
Secondary Outcome Measure Information:
Title
Analgesic consumption; duration of surgery
Time Frame
up to 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with indication of asymptomatic bilateral extractions of lower third molars
Aged 18 years or older;
Have a good health and no disease;
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Eduardo Alcântara, MsC
Organizational Affiliation
Federal University of the Valleys of Jequitinhonha and Mucuri
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal dos Vales do Jequitinhonha e Mucuri
City
Diamantina
State/Province
Minas Gerais
ZIP/Postal Code
39100000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery
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