What this study is
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.
What's being tested
- Dexamethasone IV injection
Intervention · DRUG
Dexamethasone 8mg/2ml administered intravenously at gum flap surgery
- Dexamethasone Capsule
Intervention · DRUG
Dexamethasone 8 mg capsule will be administered at gum flap surgery
- Placebo IV administration
Intervention · OTHER
Placebo used for dexamethasone IV injection at gum flap surgery
- Placebo capsule
Intervention · OTHER
Placebo capsule is administered at gum flap surgery
Study details
- Official title
- The Effect of Dexamethasone on Short Term Patient Response: Intravenous vs. Oral Administration
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Conditions
- Post Operative Pain, Acute · Periodontitis
- Enrolling
- 40 people
- Starts
- 2026-10
- Est. completion
- 2029-03
- Design
- Quadruple-blind, randomized, crossover, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age ≥ 18 years old.
- Diagnosis of periodontitis and treatment plan recommending two similar periodontal flap surgical procedures.
- The two planned periodontal surgical sites must be considered clinically similar based on extent and severity of periodontal disease, and suitable for a cross-over study design.
- Able and willing to undergo the planned periodontal flap surgeries with IV conscious sedation.
- Able to understand the study procedures and willing to sign a written informed consent document.
- Fluent in reading English, because the postoperative questionnaires and patient-reported outcome instruments will be administered in English.
- Able and willing to use the study paper survey to complete postoperative pain, swelling, and analgesic-use assessments.
- 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 completion of study visits, postoperative follow-up, and timely evaluation of any postoperative concerns.
You can't join if
- Unable to undergo periodontal surgery because of uncontrolled systemic disease, poor oral hygiene, or any clinical condition that, in the judgment of the treating clinician or Principal Investigator, would make periodontal surgery or study participation unsafe.
- Pregnancy. Pregnant participants will be excluded because of potential medication-, surgical-, and sedation-related considerations. Pregnancy status will initially be assessed by participant self-report during pre-screening prior to informed consent and will be reconfirmed by participant self-report after informed consent and before randomization. Participants of childbearing potential will also be asked to confirm a negative pregnancy status with a urine pregnancy test before each surgical visit and before administration of study medication/placebo or IV sedation. Participants will be instructed to notify the study team if they become pregnant or believe they may be pregnant at any time during the study.
- Diabetes mellitus.
- Allergy to dexamethasone or IV fluid/saline, or any component of the oral or IV placebo formulation.
- Chronic use (≥4 weeks) of anti-inflammatory, analgesic, or corticosteroid medications within the past 6 months.
- Not fluent in reading English.
- Inability to use the study paper survey to complete postoperative pain, swelling, and analgesic-use assessments.
- Unwillingness to receive IV sedation or IV access.
- Residence more than 50 miles from the UT Health San Antonio School of Dentistry.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Texas Health Science Center at San Antonio (Dental School)
San Antonio, Texas, United States
- Mostafa Shehabeldin, DDS, MS, PhD · Contact210-567-3361shehabeldin@uthscsa.edu
- Angela Paiologou-Gallis, DDS · Contact210-567-3567PalaiologouA@uthscsa.edu
- Mostafa Shehabeldin, DDS, MS, PhD · Principal investigator
- Angela Palaiologou-Gallis Palaiologou-Gallis, DDS · Principal investigator
Study team
Sponsor
The University of Texas Health Science Center at San Antonio
Study ID STUDY00002841
Principal investigator
Mostafa Shehabeldin, DDS, MS, PhD
The University of Texas Health Science Center at San Antonio
Principal investigator
Angela Paliaologou-Gallis, DDS
The University of Texas Health Science Center at San Antonio
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.