Pre-emptive Analgesics in Orthodontic Treatment

Phase 4

Completed

Brief Summary: This study is designed to determine if the preemptive use of a combination of acetaminophen and ibuprofen is more effective in reducing pain following orthodontic tooth movement when compared to the use of acetaminophen and ibuprofen alone.

Detailed Description: This study is designed to determine if the preemptive use of a combination of acetaminophen and ibuprofen is more effective in reducing pain following orthodontic tooth movement when compared to the use of acetaminophen and ibuprofen alone. Before their orthodontic appointment, participants will be administered acetaminophen (650mg), ibuprofen (400mg), or acetaminophen (650mg) + ibuprofen (400mg). Participants will be asked to record their pain intensity using a numerical (0-10) visual analog scale (VAS) during rest, light biting, and while chewing paraffin wax during the following time intervals: immediately following drug administration, 6 hours after, the morning after, and the second morning after orthodontic treatment.

Recruitment & Eligibility

Inclusion Criteria

-Orthodontic patient presenting for orthodontic treatment

Exclusion Criteria

History of taking an analgesic in the past six hours
Hypersensitivity to ibuprofen or acetaminophen
Aspirin-sensitive asthma
Renal or liver impairment
History of GI bleeding or ulcers
Cardiovascular disease, recent myocardial infarction, heart failure, or coronary artery bypass graft surgery
Currently taking antibiotics or other medications for a chronic systemic disease
Bleeding disorder
Pregnant or nursing

Arm && Interventions

Group	Intervention	Description
Acetaminophen	Acetaminophen	Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment
Ibuprofen	Ibuprofen	Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment
Acetaminophen and Ibuprofen	Acetaminophen	Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment
Acetaminophen and Ibuprofen	Ibuprofen	Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment	6 hours after orthodontic treatment	Pain scores were measured and recorded by selecting a number \[0-10\] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax. The VAS consisted of a 10cm numerical scale from 0, representing "no pain," to 10, representing "worst possible, unbearable, excruciating pain."
Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment	1 day after orthodontic treatment	Pain scores were measured and recorded by selecting a number \[0-10\] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax. The VAS consisted of a 10cm numerical scale from 0, representing "no pain," to 10, representing "worst possible, unbearable, excruciating pain."
Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment	2 days after orthodontic treatment	Pain scores were measured and recorded by selecting a number \[0-10\] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax. The VAS consisted of a 10cm numerical scale from 0, representing "no pain," to 10, representing "worst possible, unbearable, excruciating pain."