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DEXA-DENT: DEXAmethasone as an analgesic adjunct in the management of acute atraumatic DENTal pain: a pragmatic, triple-blind, parallel group, phase 3 randomised placebo-controlled trial

DEXA-DENT: Efficacy of DEXAmethasone as an analgesic adjunct in the management of acute atraumatic DENTal pain: a pragmatic, triple-blind, parallel group, phase 3 randomised placebo-controlled trial

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626001001381
Enrollment
216
Registered
2026-08-14
Start date
2026-08-17
Completion date
2027-06-17
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Dental pain is a common condition that affects 1 in 5 Australians. Access to timely dental care is often difficulty, leading to many patients seeking care from the Emergency Department, where treatment options are often limited. This study aims to evaluate the use of a single dose of dexamethasone taken as a capsule to reduce pain in patients presenting to the Emergency Department with dental pain. Dexamethasone is a cheap and readily available medication that has few side effects and an excellent safety profile.

Interventions

Single dose of 8mg oral dexamethasone. Administered as two 4mg capsules by treating nurse during their presentation at the Emergency Department (ED). Adherence will be monitored as per usual medication administration - oral medication provided along with cup of water, observed to swallow medication with sip of water. Capsules made by de-blistering and over encapsulation of 4mg dexamethasone tablets into hard gelatin capsules filled with partially pregelatinized maize starch.

Sponsors

Gold Coast University Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All adult (greater than or equal to 18 years old) patients presenting to the ED with acute atraumatic dental pain. This is defined as pain originating from the tooth or surrounding structures (including gingiva) in the absence of trauma, including but not exclusive to periodical abscess, periodontal abscess, gingivitis and pulpitis.

Exclusion criteria

Unable or unwilling to consent to study No telephone number nor ability to engage in follow up contact Clinical history of trauma related to current presentation Clinical indication for acute surgical management such as deep space infection Clinical indication for inpatient management including intravenous medications Systemically unwell including severe infection, sepsis Contraindication to corticosteroids including severe immunosuppression (transplant patients, patients undergoing active chemotherapy), clinical concern for steroid-induced psychiatric reactions Known or suspected hypersensitivity to any excipient contained in either dexamethasone or placebo Altered mental state including drug or alcohol intoxixcation Inability to take oral medication

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 31, 2026