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The Effects of Dexamethasone on the Time to Pain Resolution in Dental Periapical Abscess

University of Arizona logo

University of Arizona

Status

Completed

Conditions

Pharmaceutical Preparations, Dental
Dental Research

Treatments

Drug: Placebo Oral Capsule
Drug: oral dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT03005522
1611005004

Details and patient eligibility

About

An individual's quality of life can be seriously affected by the severity of dental pain. The emergency department is a common place to find those seeking relief from their dental pain- often times seeking removal of the affected tooth, dental anesthetic injections or oral pain medications. There are a number of dental infections that cause this type of debilitating pain. One such dental infection is termed periapical abscess. This infection involves the tooth pulp. These infections can arise in three ways: introduction through a defect in the enamel and dentin; from a periodontal pocket or an adjacent tooth; or hematogenous seeding of the pulp from mechanical irritation. As this disease process continues there are a number of complications including chronic pain and, more seriously, the spread of infection into deep spaces which can be a life threatening condition.

The Emergency Department treatment of this infection includes pain control, antibiotics and dental referral for ultimate management of the infection.

The purpose of our study is to investigate whether the addition of oral steroids will alter the time until patient experiences improvement in their dental pain. Steroids are a commonly used anti-inflammatory that is used in the Emergency Departmentfor the purpose of pain relief from throat pain. As the pain from periapical infection is thought to be largely from the pressure we speculate that the anti-inflammatory effects of steroids may decrease the inflammation thus the pressure and may ultimately lead to a decrease in time until the patient experiences some relief from their pain.

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients included if they had clinical diagnosis of pulpitis/dental apical abscess and physical exam revealed pain with percussion of the affected tooth/teeth plus or minus evidence of periapical abscess (gingival erythema, swelling, draining pus). Written informed consent was obtained from each patient prior to enrollment in the study.-

Exclusion criteria

  1. Younger than 18 years old
  2. Immunosuppression : HIV patient, transplant patient, chemotherapy
  3. History of diabetes
  4. Recent (<1 month) or chronic steroid use
  5. Hospitalization required due to intractable vomiting/pain
  6. Pregnancy, self report

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

73 participants in 2 patient groups, including a placebo group

placebo
Placebo Comparator group
Description:
dosed with placebo
Treatment:
Drug: Placebo Oral Capsule
intervention
Active Comparator group
Description:
10mg oral dexamethasone
Treatment:
Drug: oral dexamethasone

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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