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Completed

NCT Number: NCT03523988

Pre-emptive Analgesics in Orthodontic Treatment

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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Key information

Conditions

NSAID Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

12 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

Acetaminophen gel capsule

Other names: Tylenol, Paracetamol

Ibuprofen

Drug

Ibuprofen gel capsule

Other names: Advil

Primary outcomes

  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."

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Effects of Pre-emptive Use of Combined Ibuprofen and Acetaminophen on Pain Control in Orthodontic Treatment

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 14, 2018
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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