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

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.

Study Overview

• Status: Unknown
• Conditions: Dental Research; Pharmaceutical Preparations, Dental
• Intervention / Treatment: Drug: Placebo Oral Capsule; Drug: oral dexamethasone

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susanne Olkkola, MEd, MPA; Phone Number: 520-626-8819; Email: solkkola@aemrc.arizona.edu
• Study Contact Backup: Name: Isabelle Chea, BS; Phone Number: 520-626-0645; Email: ichea@aemrc.arizona.edu

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Recruiting
      • Banner University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; dosed with placebo	Drug: Placebo Oral Capsule; dosed with placebo
Active Comparator: intervention; 10mg oral dexamethasone	Drug: oral dexamethasone; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	72 hours

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Noah Tolby, MD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: December 24, 2016
• First Submitted That Met QC Criteria: December 24, 2016
• First Posted (Estimate): December 29, 2016

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 4, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Suppuration; Jaw Diseases; Periapical Diseases; Periodontitis; Abscess; Periapical Periodontitis; Periapical Abscess; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 1611005004