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
  Purpose

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.


Condition Intervention
Pain,
Edema,
Trismus
Drug: Dexamethasone
Drug: Methylprednisolone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Federal University of the Valleys of Jequitinhonha and Mucuri:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Analgesic consumption; duration of surgery [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: April 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexamethasone 8mg Drug: Dexamethasone
Dexamethasone 8mg
Other Name: Dexametasone acetate
Experimental: Methylprednisolone
Methylprednisolone 40mg
Drug: Methylprednisolone
Methylprednisolone 40mg
Other Name: Methylprednisolone

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603498

Locations
Brazil
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Diamantina, Minas Gerais, Brazil, 39100000
Sponsors and Collaborators
Federal University of the Valleys of Jequitinhonha and Mucuri
Investigators
Principal Investigator: Carlos Eduardo Alcântara, MsC Federal University of the Valleys of Jequitinhonha and Mucuri
  More Information

No publications provided

Responsible Party: Federal University of the Valleys of Jequitinhonha and Mucuri
ClinicalTrials.gov Identifier: NCT01603498     History of Changes
Other Study ID Numbers: 053/10
Study First Received: May 17, 2012
Last Updated: May 21, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of the Valleys of Jequitinhonha and Mucuri:
pain measurement,
edema,
trismus

Additional relevant MeSH terms:
Edema
Trismus
Signs and Symptoms
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Dexamethasone acetate
Methylprednisolone acetate
Prednisolone acetate
Dexamethasone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Dexamethasone 21-phosphate
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 31, 2014