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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen | Active Comparator | Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment |
|
| Ibuprofen | Active Comparator | Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment |
|
| Acetaminophen and Ibuprofen | Experimental | Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Acetaminophen gel capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Pain Scores at 6 Hours After 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." | 6 hours after orthodontic treatment |
| Visual Analog Scale (VAS) Pain Scores at 1 Day After 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." | 1 day after orthodontic treatment |
| Visual Analog Scale (VAS) Pain Scores at 2 Days After 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 days after orthodontic treatment |
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Inclusion Criteria:
-Orthodontic patient presenting for orthodontic treatment
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Marie Bollen, DDS, MS, PhD | University of Washington | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
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Participants were screened against a set of inclusion criteria during the informed consent process. If one or more of the inclusion were not met then the patient was not assigned to a group.
Orthodontic patients that presented to the University of Washington Graduate Orthodontics Clinic between May 2nd and June 23rd, 2017 were approached for recruitment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acetaminophen | Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule |
| FG001 | Ibuprofen | Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Ibuprofen: Ibuprofen gel capsule |
| FG002 | Acetaminophen and Ibuprofen | Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule Ibuprofen: Ibuprofen gel capsule |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acetaminophen | Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule |
| BG001 | Ibuprofen | Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Ibuprofen: Ibuprofen gel capsule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Scale (VAS) Pain Scores at 6 Hours After 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." | Posted | Mean | Standard Deviation | scores on a scale | 6 hours after orthodontic treatment |
|
Participants were given the contact information (phone and email) of the Lead Researcher to self-report any adverse events that occurred from the time they were administered their drug to the time of the last data entry (2 days following administration).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acetaminophen | Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Headache | General disorders | Non-systematic Assessment |
Low rate of participants returning results led to small number of participants analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lead Investigator | University of Washington | 4254668544 | akeith@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 19, 2017 | Jul 18, 2018 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 1, 2018 | Jul 18, 2018 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 26, 2017 | Jul 18, 2018 | ICF_005.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Patients of the University of Washington Graduate Orthodontics Clinic
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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.
| Ibuprofen | Drug | Ibuprofen gel capsule |
|
|
| BG002 | Acetaminophen and Ibuprofen | Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule Ibuprofen: Ibuprofen gel capsule |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Acetaminophen and Ibuprofen | Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule Ibuprofen: Ibuprofen gel capsule |
|
|
|
| Primary | Visual Analog Scale (VAS) Pain Scores at 1 Day After 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." | Posted | Mean | Standard Deviation | scores on a scale | 1 day after orthodontic treatment |
|
|
|
|
| Primary | Visual Analog Scale (VAS) Pain Scores at 2 Days After 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." | Posted | Mean | Standard Deviation | scores on a scale | 2 days after orthodontic treatment |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Ibuprofen | Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Ibuprofen: Ibuprofen gel capsule | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | Acetaminophen and Ibuprofen | Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule Ibuprofen: Ibuprofen gel capsule | 0 | 25 | 0 | 25 | 1 | 25 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| Male |
|
|
| Chewing |
|
| 0.82 |
P-value for pain scores among the three comparison groups while lightly biting. |
| Superiority |
| ANOVA | 0.69 | P-value for pain scores among the three comparison groups while chewing paraffin wax. | Superiority |
|
| Chewing |
|
| 0.31 |
P-value for pain scores among the three comparison groups while lightly biting. |
| Superiority |
| ANOVA | 0.37 | P-value for pain scores among the three comparison groups while chewing paraffin wax. | Superiority |