Post Operative Pain, AcutePhase 1/2NCT07832110
The Effect of Dexamethasone on Short Term Patient Response: IV vs Oral Administration
A Phase 1/2 study testing Dexamethasone IV injection and Dexamethasone Capsule in people with Post Operative Pain, Acute and Periodontitis, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain, Acute, Periodontitis
- What is being tested?
- Dexamethasone IV injection and Dexamethasone Capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Mar 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Texas Health Science Center at San Antonio (Dental School)
San Antonio, Texas, 78229
Mostafa Shehabeldin, DDS, MS, PhD, 210-567-3361, shehabeldin@uthscsa.edu
Angela Paiologou-Gallis, DDS, 210-567-3567, PalaiologouA@uthscsa.edu
About this study
Official title: The Effect of Dexamethasone on Short Term Patient Response: Intravenous vs. Oral Administration
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.
Read the detailed description
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.
- Conditions
- Post Operative Pain, Acute, Periodontitis
- Being tested
- Dexamethasone IV injection, Dexamethasone Capsule, Placebo IV administration, Placebo capsule
- Keywords
- Gum flap surgery, Dexamethasone, Anti-inflammatory
- Medical subject headings
- Pain, Postoperative, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone IV injectionDrug
Dexamethasone 8mg/2ml administered intravenously at gum flap surgery
Dexamethasone CapsuleDrug
Dexamethasone 8 mg capsule will be administered at gum flap surgery
Placebo IV administrationOther
Placebo used for dexamethasone IV injection at gum flap surgery
Placebo capsuleOther
Placebo capsule is administered at gum flap surgery
| Study group | Role | What they receive |
|---|---|---|
| Sequence A Cohort | Experimental | Surgery 1: IV Dexamethasone plus oral placebo Surgery 2: Oral Dexamethasone plus IV placebo Receives: Drug: Dexamethasone IV injection; Other: Placebo capsule |
| Sequence B Cohort | Experimental | Surgery 1: Oral Dexamethasone plus IV placebo Surgery 2: IV Dexamethasone plus oral placebo Receives: Drug: Dexamethasone Capsule; Other: Placebo IV administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
- = Mild
- = Moderate
- = Severe
Measured: 12 to 72 hours post surgery
Secondary outcomes (3)
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.
Measured: 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.
Measured: 12 to 72 hours post surgically
Number of patient reported analgesics post surgery
Patient-reported analgesic consumption, including ibuprofen and acetaminophen use
Measured: 12 - 72 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A single-site, randomized, blinded, placebo-controlled, cross-over clinical trial using a matched placebo blinding approach.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Shehabeldin, The University of Texas Health Science Center at San Antonio
- Investigators
- Mostafa Shehabeldin, DDS, MS, PhD, Principal investigator, The University of Texas Health Science Center at San AntonioAngela Paliaologou-Gallis, DDS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832110
- Sponsor's protocol ID
- STUDY00002841
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexamethasone on Short Term Patient Response: Intravenous vs. Oral Administration
- ClinicalTrials.gov ID
- NCT07832110
- Acronym / sponsor ID
- STUDY00002841
- Conditions
- Post Operative Pain, Acute, Periodontitis
- Keywords
- Gum flap surgery, Dexamethasone, Anti-inflammatory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A single-site, randomized, blinded, placebo-controlled, cross-over clinical trial using a matched placebo blinding approach.
| Arm | Type | Receives |
|---|---|---|
| Sequence A Cohort | Experimental | Drug: Dexamethasone IV injection, Other: Placebo capsuleSurgery 1: IV Dexamethasone plus oral placebo Surgery 2: Oral Dexamethasone plus IV placebo |
| Sequence B Cohort | Experimental | Drug: Dexamethasone Capsule, Other: Placebo IV administrationSurgery 1: Oral Dexamethasone plus IV placebo Surgery 2: IV Dexamethasone plus oral placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone IV injectionDexamethasone 8mg/2ml administered intravenously at gum flap surgery | Drug | Sequence A Cohort |
| Dexamethasone CapsuleDexamethasone 8 mg capsule will be administered at gum flap surgery | Drug | Sequence B Cohort |
| Placebo IV administrationPlacebo used for dexamethasone IV injection at gum flap surgery | Other | Sequence B Cohort |
| Placebo capsulePlacebo capsule is administered at gum flap surgery | Other | Sequence A Cohort |
Primary outcome
21-point numerical pain rating scale (NRS-21)
Time frame: 12 to 72 hours post surgery
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)
Time frame: 12 to 72 hours post surgery
A rating scale used to assess pain by score rated from 0-3 where; 0 = None (No pain) 1. = Mild 2. = Moderate 3. = Severe
3 secondary outcomes
Patient reported Postoperative swelling using NRS-21
Time frame: 12-72 hours post surgery
Swelling rating using VRS-4
Time frame: 12 to 72 hours post surgically
Number of patient reported analgesics post surgery
Time frame: 12 - 72 hours post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mostafa Shehabeldin, DDS, MS, PhD principal investigator
The University of Texas Health Science Center at San Antonio
Angela Paliaologou-Gallis, DDS principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dexamethasone IV injection and Dexamethasone Capsule in people with Post Operative Pain, Acute and Periodontitis, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Shehabeldin, DDS, MS, PhD (210-567-3361, shehabeldin@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
21-point numerical pain rating scale (NRS-21) (time frame: 12 to 72 hours post surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.