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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 : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Keith, University of Washington

Tracking Information
First Submitted Date  ICMJE April 19, 2018
First Posted Date  ICMJE May 14, 2018
Results First Submitted Date  ICMJE August 3, 2018
Results First Posted Date  ICMJE October 30, 2018
Last Update Posted Date October 30, 2018
Actual Study Start Date  ICMJE May 2, 2017
Actual Primary Completion Date June 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
  • 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."
  • 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."
  • 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."
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
  • Pain Score [ 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 each of the following: 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."
  • Pain Score [ 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 each of the following: 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."
  • Pain Score [ 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 each of the following: 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."
Change History Complete list of historical versions of study NCT03523988 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pre-emptive Analgesics in Orthodontic Treatment
Official Title  ICMJE Effects of Pre-emptive Use of Combined Ibuprofen and Acetaminophen on Pain Control in Orthodontic Treatment
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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • NSAID
  • Pain Management
Intervention  ICMJE
  • Drug: Acetaminophen
    Acetaminophen gel capsule
    Other Names:
    • Tylenol
    • Paracetamol
  • Drug: Ibuprofen
    Ibuprofen gel capsule
    Other Name: Advil
Study Arms  ICMJE
  • Active Comparator: Acetaminophen
    Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment
    Intervention: Drug: Acetaminophen
  • Active Comparator: Ibuprofen
    Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment
    Intervention: Drug: Ibuprofen
  • Experimental: Acetaminophen and Ibuprofen
    Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment
    Interventions:
    • Drug: Acetaminophen
    • Drug: Ibuprofen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2018)
73
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 1, 2017
Actual Primary Completion Date June 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 59 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03523988
Other Study ID Numbers  ICMJE STUDY00001679
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Andrew Keith, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Anne-Marie Bollen, DDS, MS, PhD University of Washington
PRS Account University of Washington
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP