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

NCT ID: NCT03005522

Last Updated: 2022-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

placebo

dosed with placebo

Group Type: PLACEBO_COMPARATOR

Placebo Oral Capsule

Intervention Type: DRUG

dosed with placebo

intervention

10mg oral dexamethasone

Group Type: ACTIVE_COMPARATOR

oral dexamethasone

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Placebo Oral Capsule

dosed with placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Noah Tolby

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noah Tolby, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

Banner University Medical Center

Tucson, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1611005004

Identifier Type: -

Identifier Source: org_study_id