The Effect of Dexamethasone on Short Term Patient Response: IV vs Oral Administration

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT07832110
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Periodontitis
  • Post Operative Pain, Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone IV injection — DRUG
    Dexamethasone 8mg/2ml administered intravenously at gum flap surgery
  • Dexamethasone Capsule — DRUG
    Dexamethasone 8 mg capsule will be administered at gum flap surgery
  • Placebo IV administration — OTHER
    Placebo used for dexamethasone IV injection at gum flap surgery
  • Placebo capsule — OTHER
    Placebo capsule is administered at gum flap surgery

Study Details

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.

Key Dates

First listed
Sep 21, 2026
Start date
Oct 31, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sequence A Cohort
    Surgery 1: IV Dexamethasone plus oral placebo Surgery 2: Oral Dexamethasone plus IV placebo
  • Experimental: Sequence B Cohort
    Surgery 1: Oral Dexamethasone plus IV placebo Surgery 2: IV Dexamethasone plus oral placebo

Primary Outcome Measure

21-point numerical pain rating scale (NRS-21) [ Time Frame: 12 to 72 hours post surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Health Science Center at San Antonio (Dental School)San AntonioTexas78229
Mostafa Shehabeldin, DDS, MS, PhD
[email protected]
210-567-3361
Angela Paiologou-Gallis, DDS
[email protected]
210-567-3567
Mostafa Shehabeldin, DDS, MS, PhD (PRINCIPAL_INVESTIGATOR)
Angela Palaiologou-Gallis Palaiologou-Gallis, DDS (PRINCIPAL_INVESTIGATOR)

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University of Texas Health Science Center at San Antonio (Dental School)· San Antonio, TX

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