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OpenTrials
Completed

NCT Number: NCT05752305

Use of Corticosteroids in Third Molar Surgery

Surgical extraction of retained lower third molars is associated with the development of postoperative complications, including inflammation, trismus and postoperative pain, that lead to a decrease in patients' quality of life. Therefore, the use of drugs is essential to reduce the morbidity associated with surgery, with NSAIDs and corticosteroids being the most commonly used drugs.

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Key information

Conditions

Inflammation Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Spasm Trismus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Unai Fernández Martín

Granada, Spain

About this study

Surgical extraction of retained lower third molars is associated with the development of postoperative complications, including inflammation, trismus and postoperative pain. Traditionally, NSAIDs have been used for the treatment of postoperative pain and inflammation, although corticosteroids are increasingly used in oral surgery, as they have proven to be clinically effective in reducing postoperative complications without causing serious adverse effects. Although numerous studies have been carried out comparing different corticosteroids in order to determine which of them is the most effective, there is still no clinical protocol regulating the use of these drugs in oral surgery. Therefore, this clinical trial is based on comparing two of the most studied corticosteroids used in oral surgery to date: dexamethasone and methylprednisolone.

This study is based on the preoperative administration of 8mg of dexamethasone or 40mg of methylprednisolone via submucosa, randomly, in patients undergoing surgical extraction of a retained lower third molar, to determine which of these two drugs is more effective in the prevention of inflammation, trismus and postoperative pain.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients over 18 years of age
  • Indication for surgical extraction of a retained lower third molar

Exclusion criteria

  • Patients treated with corticosteroids in the last 3 months
  • Patients treated with NSAIDs in the last 7 days
  • Patients with hypersensitivity to the drug
  • Patients with a medical condition that contraindicates the administration of the drug

Treatment and study plan

Dexamethasone 4 Mg/mL Injectable Solution

Drug

Preoperative submucosal administration of 8mg of dexamethasone or 40mg of methylprednisolone.

MethylPREDNISolone 40 Mg/mL Injectable Suspension

Drug

Preoperative submucosal administration of 8mg of dexamethasone or 40mg of methylprednisolone.

Primary outcomes

  1. Postoperative inflammation following third molar surgical extraction

    Time frame: 7 days

    Postoperative swelling was determined by measuring tragus-chin distance, tragus-labial cleft distance and eye angle-jaw angle distance, using a millimeter ruler.

  2. Postoperative trismus following third molar surgical extraction

    Time frame: 7 days

    Postoperative trismus was assessed by measuring the patient's maximum mouth opening (measuring the distance between the incisal edge of the upper central incisor and the lower central incisor) using a millimeter ruler.

  3. Postoperative pain following third molar surgical extraction

    Time frame: 7 days

    Postoperative pain was measured using the Visual Analogue Scale (VAS): patients were asked to assign a numerical value from 0-100 (0 being no pain and 100 the maximum pain).

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

Effect of Preoperative Administration of Dexamethasone Versus Methylprednisolone in Surgical Extraction of Retained Lower Third Molars

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2023
Registry last updated
Dec 6, 2023

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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