Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Federal University of the Valleys of Jequitinhonha and Mucuri
ClinicalTrials.gov Identifier:
NCT01603498
First received: May 17, 2012
Last updated: May 21, 2012
Last verified: May 2012

May 17, 2012
May 21, 2012
April 2011
December 2011   (final data collection date for primary outcome measure)
Postoperative sequelae following thir molar extraction [ Time Frame: up to seven days postoperative ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01603498 on ClinicalTrials.gov Archive Site
Analgesic consumption; duration of surgery [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pain,
  • Edema,
  • Trismus
  • Drug: Dexamethasone
    Dexamethasone 8mg
    Other Name: Dexametasone acetate
  • Drug: Methylprednisolone
    Methylprednisolone 40mg
    Other Name: Methylprednisolone
  • Experimental: Dexamethasone 8mg
    Intervention: Drug: Dexamethasone
  • Experimental: Methylprednisolone
    Methylprednisolone 40mg
    Intervention: Drug: Methylprednisolone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01603498
053/10
Yes
Federal University of the Valleys of Jequitinhonha and Mucuri
Federal University of the Valleys of Jequitinhonha and Mucuri
Not Provided
Principal Investigator: Carlos Eduardo Alcântara, MsC Federal University of the Valleys of Jequitinhonha and Mucuri
Federal University of the Valleys of Jequitinhonha and Mucuri
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP