The Effects of Dexamethasone on the Time to Pain Resolution in Dental Periapical Abscess
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|ClinicalTrials.gov Identifier: NCT03005522|
Recruitment Status : Recruiting
First Posted : December 29, 2016
Last Update Posted : May 10, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Dental Research Pharmaceutical Preparations, Dental||Drug: oral dexamethasone Drug: Placebo Oral Capsule||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effects of Dexamethasone on the Time to Pain Resolution in Dental Periapical Abscess|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
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
- decrease time of oral pain [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03005522
|Contact: Susanne Olkkola, MEd, MPAfirstname.lastname@example.org|
|Contact: Isabelle Chea, BSemail@example.com|
|United States, Arizona|
|Banner University Medical Center||Recruiting|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Noah Tolby, MD||University of Arizona|