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

Not Applicable

Completed

• Conditions: Dental Research; Pharmaceutical Preparations, Dental
• Interventions: Drug: Placebo Oral Capsule; Drug: oral dexamethasone

• Registration Number: NCT03005522
• Lead Sponsor: University of Arizona

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-24
• Study First Submitted QC: 2016-12-24
• Study First Posted: 2016-12-29
• Study Start: 2017-01
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2022-11
• Results First Submitted: 2022-11-05
• Results First Submitted QC: 2022-11-29
• Last Update Submitted: 2022-11-29
• Results First Posted: 2022-12-28
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
placebo	Placebo Oral Capsule	dosed with placebo
intervention	oral dexamethasone	10mg oral dexamethasone

Primary Outcome Measures

Name	Time	Method
Decrease Time of Oral Pain	72 hours	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

Trial Locations

Locations (1)

Banner University Medical Center; 🇺🇸 Tucson, Arizona, United States