Pre-emptive Analgesics in Orthodontic Treatment

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-02

Study Completion Date

2017-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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NSAID Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients of the University of Washington Graduate Orthodontics Clinic

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

The medications were prepared by the Kelley-Ross Compounding Group (Seattle, WA) and were identical in appearance. The bottles were labeled as "A", "B", or "C" and the identity of the medications were not revealed until after the data analysis was completed.

Study Groups

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Acetaminophen

Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

Acetaminophen gel capsule

Ibuprofen

Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Ibuprofen gel capsule

Acetaminophen and Ibuprofen

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

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

Acetaminophen gel capsule

Ibuprofen

Intervention Type DRUG

Ibuprofen gel capsule

Interventions

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Acetaminophen

Acetaminophen gel capsule

Intervention Type DRUG

Ibuprofen

Ibuprofen gel capsule

Intervention Type DRUG

Other Intervention Names

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Tylenol Paracetamol Advil

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes