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.
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.
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.
Crossover
Dexamethasone IV injection
DrugDexamethasone 8mg/2ml administered intravenously at gum flap surgery
Dexamethasone Capsule
DrugDexamethasone 8 mg capsule will be administered at gum flap surgery
Placebo IV administration
Other interventionPlacebo used for dexamethasone IV injection at gum flap surgery
Placebo capsule
Other interventionPlacebo capsule is administered at gum flap surgery
21-point numerical pain rating scale (NRS-21)
Change in pain on NRS-21, a 21 item scale that is scored using a numeric scale where patients choose from 0-20: 0: No pain at all 1 - 6: Mild pain (noticeable but doesn't disrupt activities) 7 - 13: Moderate pain (interferes significantly with focus, tasks, or sleep) 14 - 20: Severe / Worst imaginable pain (debilitating, unbearable)
Pain assessment using Verbal Rating Scale (VRS-4)
A rating scale used to assess pain by score rated from 0-3 where; 0 = None (No pain) 1. = Mild 2. = Moderate 3. = Severe
Patient reported Postoperative swelling using NRS-21
The scale uses integers or half-integers from 0-10 spread across 21 distinct points: 0 represents no swelling. 10 represents the worst or most severe swelling imaginable.
Swelling rating using VRS-4
The 4-point pitting edema scale grades swelling depth and how long the skin takes to rebound after pressure graded from 1-4: Grade 1+ (Trace/Mild): Depth of 2 mm; skin rebounds immediately. Grade 2+ (Mild/Moderate): Depth of 3 to 4 mm; skin rebounds in less than 15 seconds. Grade 3+ (Moderate): Depth of 5 to 6 mm; skin takes 10 to 30 seconds (or longer) to rebound. Grade 4+ (Severe): Depth greater than 8 mm; skin takes more than 20 to 30 seconds (up to a few minutes) to rebound.
Number of patient reported analgesics post surgery
Patient-reported analgesic consumption, including ibuprofen and acetaminophen use
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