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Completed

NCT Number: NCT01603498

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

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.

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Key information

Conditions

Pain, Edema Edema, Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm Trismus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal dos Vales do Jequitinhonha e Mucuri

Diamantina, Minas Gerais, 39100000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Dexamethasone 8mg

Other names: Dexametasone acetate

methylprednisolone

Drug

Methylprednisolone 40mg

Primary outcomes

  1. Postoperative sequelae following thir molar extraction

    Time frame: 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 outcomes

  1. Analgesic consumption; duration of surgery

    Time frame: up to 7 days

Sponsors and collaborators

Lead sponsor

Federal University of the Valleys of Jequitinhonha and Mucuri

Other

Registry information

Official study title

Preemptive Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery: a Split-mouth Randomized Triple-blind Clinical Trial

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 23, 2012
Registry last updated
May 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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