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

Not Applicable

Completed

• Conditions: Pain,; Edema,; Trismus
• Interventions: Drug: Dexamethasone; Drug: Methylprednisolone

• Registration Number: NCT01603498
• Lead Sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri

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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-05
• Study First Submitted: 2012-05-17
• Study First Submitted QC: 2012-05-21
• Last Update Submitted: 2012-05-21
• Study First Posted: 2012-05-23
• Last Update Posted: 2012-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dexamethasone 8mg	Dexamethasone	-
Methylprednisolone	Methylprednisolone	Methylprednisolone 40mg

Primary Outcome Measures

Name	Time	Method
Postoperative sequelae following thir molar extraction	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

Secondary Outcome Measures

Name	Time	Method
Analgesic consumption; duration of surgery	up to 7 days

Trial Locations

Locations (1)

Universidade Federal dos Vales do Jequitinhonha e Mucuri; 🇧🇷 Diamantina, Minas Gerais, Brazil