Trial Outcomes & Findings for The Effects of Dexamethasone on the Time to Pain Resolution in Dental Periapical Abscess (NCT NCT03005522)

NCT ID: NCT03005522

Last Updated: 2022-12-28

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 73 participants
• Primary outcome timeframe: 72 hours
• Results posted on: 2022-12-28

Participant Flow

Participant milestones

Measure	Placebo dosed with placebo Placebo Oral Capsule: dosed with placebo	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
Overall Study STARTED	36	37
Overall Study COMPLETED	25	27
Overall Study NOT COMPLETED	11	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

data on race and ethnicity were not collected

Baseline characteristics by cohort

Measure	Placebo n=25 Participants dosed with placebo Placebo Oral Capsule: dosed with placebo	Intervention n=27 Participants 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	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=25 Participants	0 Participants n=27 Participants	0 Participants n=52 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=25 Participants	27 Participants n=27 Participants	52 Participants n=52 Participants
Age, Categorical >=65 years	0 Participants n=25 Participants	0 Participants n=27 Participants	0 Participants n=52 Participants
Age, Continuous	35.1 years STANDARD_DEVIATION 10.8 • n=25 Participants	33.9 years STANDARD_DEVIATION 9.44 • n=27 Participants	34.4 years STANDARD_DEVIATION 10.09 • n=52 Participants
Sex: Female, Male Female	12 Participants n=25 Participants	13 Participants n=27 Participants	25 Participants n=52 Participants
Sex: Female, Male Male	13 Participants n=25 Participants	14 Participants n=27 Participants	27 Participants n=52 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	—	0 Participants data on race and ethnicity were not collected
Race (NIH/OMB) Asian	—	—	0 Participants data on race and ethnicity were not collected
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	—	0 Participants data on race and ethnicity were not collected
Race (NIH/OMB) Black or African American	—	—	0 Participants data on race and ethnicity were not collected
Race (NIH/OMB) White	—	—	0 Participants data on race and ethnicity were not collected
Race (NIH/OMB) More than one race	—	—	0 Participants data on race and ethnicity were not collected
Race (NIH/OMB) Unknown or Not Reported	—	—	0 Participants data on race and ethnicity were not collected
Region of Enrollment United States	25 participants n=25 Participants	27 participants n=27 Participants	52 participants n=52 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Placebo n=25 Participants dosed with placebo Placebo Oral Capsule: dosed with placebo	Intervention n=27 Participants 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
Decrease Time of Oral Pain At presentation	9 score on a scale Interval 8.0 to 10.0	9 score on a scale Interval 8.0 to 10.0
Decrease Time of Oral Pain At discharge	5 score on a scale Interval 2.0 to 7.0	4 score on a scale Interval 2.0 to 7.0
Decrease Time of Oral Pain At 12 hours	5 score on a scale Interval 3.0 to 8.0	1 score on a scale Interval 0.0 to 5.0
Decrease Time of Oral Pain At 24 hours	3 score on a scale Interval 1.0 to 7.0	2 score on a scale Interval 0.0 to 5.0
Decrease Time of Oral Pain At 48 hours	3 score on a scale Interval 0.0 to 7.0	0 score on a scale Interval 0.0 to 2.0
Decrease Time of Oral Pain At 72 hours	1 score on a scale Interval 0.0 to 7.0	0 score on a scale Interval 0.0 to 2.0

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Noah Tolby

Banner University Medical Center

Phone: 520-694-8888

Email: ntolby@aemrc.arizona.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place