Clinical trial NCT03005522: The Effects of Dexamethasone on the Time to Pain Resolution in Dental Periapical Abscess
Official title: The Effects of Dexamethasone on the Time to Pain Resolution in Dental Periapical Abscess
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Research
Pharmaceutical Preparations, Dental
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Decrease Time of Oral Pain
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Noah Tolby, MD
role: PRINCIPAL_INVESTIGATOR
References: