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

There will be two randomized treatment sequences and two study intervention conditions: intravenous dexamethasone with oral placebo, and oral dexamethasone with intravenous placebo. Each participant will receive both intervention conditions and will serve as his or her own control. This cross-over design was selected to reduce between-participant variability in pain perception, inflammatory response, medication use, and healing patterns. The matched placebo blinding approach was selected to preserve blinding while allowing comparison of two different routes of administration.

The study intervention consists of a single preoperative dose of dexamethasone administered either intravenously or orally prior to each periodontal flap surgery. Placebo will be administered by the alternate route at each surgical visit to maintain blinding. The intervention duration for each surgical visit is limited to the single preoperative dosing event. Follow-up outcome assessments will occur at 12, 24, 48 and 72 hours after each periodontal surgery.

No separate placebo-only or no-treatment control group will be used because the primary study question is whether oral dexamethasone provides comparable short-term patient-centered outcomes to intravenous dexamethasone. Prior periodontal studies have already evaluated dexamethasone compared with placebo or control therapy. In this design, each participant serves as his or her own control by receiving dexamethasone through both routes during two similar surgical procedures.

Inclusion criteria

• 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.

Exclusion criteria

• 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.