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

NCT01603498 | Completed DMC

• 1 other identifier: 053/10
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain,; Edema,; Trismus

Keywords

pain measurement,; edema,; trismus

Outcome Measures

Primary Outcomes (1)

• 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

  up to seven days postoperative

Secondary Outcomes (1)

• Analgesic consumption; duration of surgery

  up to 7 days

Study Arms (2)

Dexamethasone 8mg

EXPERIMENTAL

Drug: Dexamethasone

Methylprednisolone

EXPERIMENTAL

Methylprednisolone 40mg

Drug: Methylprednisolone

Interventions

Dexamethasone DRUG

Dexamethasone 8mg

Also known as: Dexametasone acetate

Dexamethasone 8mg

Methylprednisolone DRUG

Methylprednisolone 40mg

Methylprednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with indication of asymptomatic bilateral extractions of lower third molars
• Aged 18 years or older;
• Have a good health and no disease;

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of the Valleys of Jequitinhonha and Mucuri: lead

Study Sites (1)

Universidade Federal dos Vales do Jequitinhonha e Mucuri

Diamantina, Minas Gerais, 39100000, Brazil

Location

MeSH Terms

Conditions

Pain; Edema; Trismus

Interventions

Dexamethasone; Methylprednisolone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Prednisolone

Study Officials

• Carlos Eduardo Alcântara, MsC

  Federal University of the Valleys of Jequitinhonha and Mucuri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: May 23, 2012
• Study Start: April 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 23, 2012

Record last verified: 2012-05

Locations

BR (1)