The University of Texas Health Science Center at San Antonio
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.
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 interv…
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Diagnosis of periodontitis and treatment plan recommending two similar periodontal flap surgical procedures. 3. 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. 4. Able and willing to undergo the planned periodontal flap surgeries with IV conscious sedation. 5. Able to understand the study procedures and willing to sign a written informed consent document. 6. Fluent in reading English, because the postoperative questionn…
Dexamethasone 8mg/2ml administered intravenously at gum flap surgery
Dexamethasone 8 mg capsule will be administered at gum flap surgery
Placebo used for dexamethasone IV injection at gum flap surgery
Placebo capsule is administered at gum flap surgery