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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
Sponsor:
Information provided by (Responsible Party):
Noah Tolby, 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.


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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Susanne Olkkola, MEd, MPA 520-626-8819 solkkola@aemrc.arizona.edu
Contact: Isabelle Chea, BS 520-626-0645 ichea@aemrc.arizona.edu

Locations
United States, Arizona
Banner University Medical Center Recruiting
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Noah Tolby, MD University of Arizona

Responsible Party: Noah Tolby, Principle Investigator, University of Arizona
ClinicalTrials.gov Identifier: NCT03005522     History of Changes
Other Study ID Numbers: 1611005004
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Periapical Abscess
Abscess
Suppuration
Infection
Periapical Periodontitis
Periapical Diseases
Jaw Diseases
Stomatognathic Diseases
Periodontal Diseases
Mouth Diseases
Periodontitis
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action