A Phase 1/2 interventional study of Dexamethasone IV injection and Dexamethasone Capsule in Post Operative Pain, Acute and Periodontitis, sponsored by The University of Texas Health Science Center at San Antonio. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by The University of Texas Health Science Center at San Antonio · Phase 1/2, Interventional, and Treatment
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 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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 40 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 445 studies on the registry; 89 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 35 (54%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Surgery 1: IV Dexamethasone plus oral placebo Surgery 2: Oral Dexamethasone plus IV placebo
Drug: Dexamethasone IV injection · Other: Placebo capsule
Surgery 1: Oral Dexamethasone plus IV placebo Surgery 2: IV Dexamethasone plus oral placebo
Drug: Dexamethasone Capsule · Other: Placebo IV administration
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
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)
Time frame: 12 to 72 hours post surgery
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
Time frame: 12 to 72 hours post surgery
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.
Time frame: 12-72 hours post surgery
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.
Time frame: 12 to 72 hours post surgically
Number of patient reported analgesics post surgery
Patient-reported analgesic consumption, including ibuprofen and acetaminophen use
Time frame: 12 - 72 hours post surgery
Plan to share: Yes — Individual Participant Data (IPD) will be shared with the study team during the conduct of the study. After completion, all data will be deidentified and aggregate data shared in summary results on ClinicalTrials.gov and in a peer review journal.
Supporting information: Study protocol, Statistical analysis plan
Time frame: IPD will be shared during the conduct of the study and deidentified data will be shared at the conclusion of the study after data analysis is complete and ready for publication.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2028, 26 months later.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone
The University of Texas Health Science Center at San Antonio →