Dexamethasone for Postoperative Pain

AP
MS
Overseen ByMostafa Shehabeldin, DDS, MS, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: The University of Texas Health Science Center at San Antonio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Possible participants will be scheduled to have 2 gum flap surgeries done on 2 similar surgical sites in the mouth. The study looks at two different ways of giving dexamethasone, a medication used to reduce inflammation. The researchers want to learn if taking dexamethasone by mouth works similarly to receiving dexamethasone through the participant's vein (intravenous, or IV) in reducing short-term pain, swelling, and pain medication after periodontal (gum) flap surgery.

The periodontal evaluation, treatment planning, IV sedation, gum surgery, sutures, and usual postoperative care are part of standard care and would be done even if a participant does not join the study. After joining the study, participants will be randomly assigned to the order in which they receive dexamethasone. At one surgery, participants will receive IV dexamethasone plus oral placebo (an inactive substance that looks the same but does not contain dexamethasone). At the next surgery, participants will receive oral dexamethasone plus IV placebo. As part of the study, participants will be asked to record your pain, swelling and any other medication use.

Who Is on the Research Team?

MS

Mostafa Shehabeldin, DDS, MS, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

AP

Angela Paliaologou-Gallis, DDS

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for people scheduled to have two gum flap surgeries in their mouth. Participants must be able to take both oral and IV medications, and will need to record their pain and swelling after surgery.

Inclusion Criteria

Fluent in reading English due to postoperative questionnaires and patient-reported outcome instruments being in English
Willing and able to comply with all study procedures including postoperative outcome reporting at 12, 24, 48, and 72 hours after each surgery
Resides within 50 miles of the University of Texas San Antonio School of Dentistry to facilitate study visits, follow-up, and timely evaluation of postoperative concerns
See 6 more

Exclusion Criteria

Not fluent in reading English
Inability to use study paper survey for postoperative assessments
Residence more than 50 miles from UT Health San Antonio School of Dentistry
See 6 more

What Are the Treatments Tested in This Trial?

Interventions

  • Dexamethasone Capsule
  • Dexamethasone IV injection

Trial Overview

The study compares dexamethasone given by mouth versus through an IV to see which works better at reducing short-term pain and swelling after gum surgery. Each participant receives both forms of the drug at different surgeries, with placebos used for comparison.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Sequence B CohortExperimental Treatment2 Interventions
Group II: Sequence A CohortExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+