The Effects of Dexamethasone on the Time to Pain Resolution in Dental Periapical Abscess
Primary Purpose
Dental Research, Pharmaceutical Preparations, Dental
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
oral dexamethasone
Placebo Oral Capsule
Sponsored by
About this trial
This is an interventional treatment trial for Dental Research
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:
- 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
Sites / Locations
- Banner University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
intervention
Arm Description
dosed with placebo
10mg oral dexamethasone
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03005522
First Posted
December 24, 2016
Last Updated
November 29, 2022
Sponsor
University of Arizona
1. Study Identification
Unique Protocol Identification Number
NCT03005522
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Research, Pharmaceutical Preparations, Dental
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
dosed with placebo
Arm Title
intervention
Arm Type
Active Comparator
Arm Description
10mg oral dexamethasone
Intervention Type
Drug
Intervention Name(s)
oral dexamethasone
Intervention Description
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
Intervention Name(s)
Placebo Oral Capsule
Intervention Description
dosed with placebo
Primary Outcome Measure Information:
Title
Decrease Time of Oral Pain
Description
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
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noah Tolby, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner University Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effects of Dexamethasone on the Time to Pain Resolution in Dental Periapical Abscess
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