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

NCT03005522 | Completed Results

• 1 other identifier: 1611005004
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Research; Pharmaceutical Preparations, Dental

Outcome Measures

Primary Outcomes (1)

• Decrease Time of Oral Pain

  The purpose of this study is to investigate whether the addition of oral steroids will alter the time until patient experiences improvement in their dental pain from an acute dental periapical abscess. The patients will be randomized to receive either dexamethasone or placebo. The patients will be contacted over a period 72 hours to assess their level of pain resolution. Pain was reported using a verbal numeric scale in which 10=maximum pain and 0=no pain

  72 hours

Study Arms (2)

placebo

PLACEBO COMPARATOR

dosed with placebo

Drug: Placebo Oral Capsule

intervention

ACTIVE COMPARATOR

10mg oral dexamethasone

Drug: oral dexamethasone

Interventions

oral dexamethasone DRUG

Patient will be dosed with either placebo or with the study drug, 10mg oral dexamethasone, to be administered by mouth one time in the ED

intervention

Placebo Oral Capsule DRUG

dosed with placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.-

You may not qualify if:

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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr Noah Tolby
• Organization: Banner University Medical Center

ntolby@aemrc.arizona.edu

520-694-8888

Study Officials

• Noah Tolby, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 24, 2016
• First Posted: December 29, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 28, 2022
• Results First Posted: December 28, 2022

Record last verified: 2022-11

Locations

US (1)