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Pre-emptive Analgesics in Orthodontic Treatment

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ClinicalTrials.gov Identifier: NCT03523988
Recruitment Status : Completed
First Posted : May 14, 2018
Results First Posted : October 30, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew Keith, University of Washington

Study Description
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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.

Condition or disease Intervention/treatment Phase
NSAID Pain Management Drug: Acetaminophen Drug: Ibuprofen Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients of the University of Washington Graduate Orthodontics Clinic
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Effects of Pre-emptive Use of Combined Ibuprofen and Acetaminophen on Pain Control in Orthodontic Treatment
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : June 23, 2017
Actual Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Acetaminophen
Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment
 Drug: Acetaminophen
Acetaminophen gel capsule
Other Names:
  • Tylenol
  • Paracetamol
Active Comparator: Ibuprofen
Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment
 Drug: Ibuprofen
Ibuprofen gel capsule
Other Name: Advil
Experimental: Acetaminophen and Ibuprofen
Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment
 Drug: Acetaminophen
Acetaminophen gel capsule
Other Names:
  • Tylenol
  • Paracetamol

Drug: Ibuprofen
Ibuprofen gel capsule
Other Name: Advil


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment [ Time Frame: 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."


  2. Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment [ Time Frame: 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."


  3. Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment [ Time Frame: 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."



Eligibility Criteria
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Ages Eligible for Study:   12 Years to 59 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT03523988


Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
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Study Director: Anne-Marie Bollen, DDS, MS, PhD University of Washington
  Study Documents (Full-Text)

Documents provided by Andrew Keith, University of Washington:
Study Protocol  [PDF] April 19, 2017
Statistical Analysis Plan  [PDF] May 1, 2018
Informed Consent Form  [PDF] April 26, 2017

More Information
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Responsible Party: Andrew Keith, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT03523988    
Other Study ID Numbers: STUDY00001679
First Posted: May 14, 2018    Key Record Dates
Results First Posted: October 30, 2018
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Andrew Keith, University of Washington:
Pre-emptive analgesics
Acetaminophen
Ibuprofen
Additional relevant MeSH terms:
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Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action