Dental Research, Pharmaceutical Preparations, Dental
Conditions
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.
Interventions
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
DRUGPlacebo Oral Capsule
dosed with placebo
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo dosed with placebo
Placebo Oral Capsule: dosed with placebo | 25 |
| Intervention 10mg oral dexamethasone
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 | 27 |
| Total | 52 |
Baseline characteristics
| Characteristic | Placebo | Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 27 Participants | 52 Participants |
| Age, Continuous | 35.1 years STANDARD_DEVIATION 10.8 | 33.9 years STANDARD_DEVIATION 9.44 | 34.4 years STANDARD_DEVIATION 10.09 |
| Race (NIH/OMB) American Indian or Alaska Native | — | — | 0 Participants |
| Race (NIH/OMB) Asian | — | — | 0 Participants |
| Race (NIH/OMB) Black or African American | — | — | 0 Participants |
| Race (NIH/OMB) More than one race | — | — | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | — | — | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | — | — | 0 Participants |
| Race (NIH/OMB) White | — | — | 0 Participants |
| Region of Enrollment United States | 25 participants | 27 participants | 52 participants |
| Sex: Female, Male Female | 12 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Male | 13 Participants | 14 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 27 |
| other Total, other adverse events | 0 / 25 | 0 / 27 |
| serious Total, serious adverse events | 0 / 25 | 0 / 27 |
Outcome results
Primary
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
Time frame: 72 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Decrease Time of Oral Pain | At discharge | 5 score on a scale |
| Placebo | Decrease Time of Oral Pain | At 24 hours | 3 score on a scale |
| Placebo | Decrease Time of Oral Pain | At presentation | 9 score on a scale |
| Placebo | Decrease Time of Oral Pain | At 48 hours | 3 score on a scale |
| Placebo | Decrease Time of Oral Pain | At 12 hours | 5 score on a scale |
| Placebo | Decrease Time of Oral Pain | At 72 hours | 1 score on a scale |
| Intervention | Decrease Time of Oral Pain | At 72 hours | 0 score on a scale |
| Intervention | Decrease Time of Oral Pain | At presentation | 9 score on a scale |
| Intervention | Decrease Time of Oral Pain | At discharge | 4 score on a scale |
| Intervention | Decrease Time of Oral Pain | At 12 hours | 1 score on a scale |
| Intervention | Decrease Time of Oral Pain | At 24 hours | 2 score on a scale |
| Intervention | Decrease Time of Oral Pain | At 48 hours | 0 score on a scale |