Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pre-emptive Analgesics in Orthodontic Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions NSAID
Pain Management
Interventions Drug: Acetaminophen
Drug: Ibuprofen
Enrollment 73
Recruitment Details Orthodontic patients that presented to the University of Washington Graduate Orthodontics Clinic between May 2nd and June 23rd, 2017 were approached for recruitment.
Pre-assignment Details 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.
Arm/Group Title Acetaminophen Ibuprofen Acetaminophen and Ibuprofen
Hide Arm/Group Description

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

Acetaminophen: Acetaminophen gel capsule

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

Ibuprofen: Ibuprofen gel capsule

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

Acetaminophen: Acetaminophen gel capsule

Ibuprofen: Ibuprofen gel capsule

Period Title: Overall Study
Started 24 24 25
Completed 7 8 7
Not Completed 17 16 18
Arm/Group Title Acetaminophen Ibuprofen Acetaminophen and Ibuprofen Total
Hide Arm/Group Description

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

Acetaminophen: Acetaminophen gel capsule

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

Ibuprofen: Ibuprofen gel capsule

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

Acetaminophen: Acetaminophen gel capsule

Ibuprofen: Ibuprofen gel capsule

Total of all reporting groups
Overall Number of Baseline Participants 7 8 7 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 8 participants 7 participants 22 participants
21.7  (9.6) 25.9  (18.0) 21.4  (15.3) 23.1  (14.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 8 participants 7 participants 22 participants
Female
6
  85.7%
3
  37.5%
3
  42.9%
12
  54.5%
Male
1
  14.3%
5
  62.5%
4
  57.1%
10
  45.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 8 participants 7 participants 22 participants
7 8 7 22
1.Primary Outcome
Title Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment
Hide Description

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.”

Time Frame 6 hours after orthodontic treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Ibuprofen Acetaminophen and Ibuprofen
Hide Arm/Group Description:

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

Acetaminophen: Acetaminophen gel capsule

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

Ibuprofen: Ibuprofen gel capsule

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

Acetaminophen: Acetaminophen gel capsule

Ibuprofen: Ibuprofen gel capsule

Overall Number of Participants Analyzed 7 8 7
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Rest 0.6  (0.8) 2.6  (2.2) 1.0  (1.0)
Biting 2.0  (1.4) 2.9  (2.5) 2.0  (1.9)
Chewing 2.3  (1.4) 4.0  (3.1) 3.1  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acetaminophen, Ibuprofen, Acetaminophen and Ibuprofen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments P-value for pain scores among the three comparison groups with jaw at rest.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Acetaminophen, Ibuprofen, Acetaminophen and Ibuprofen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments P-value for pain scores among the three comparison groups while lightly biting.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Acetaminophen, Ibuprofen, Acetaminophen and Ibuprofen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments P-value for pain scores among the three comparison groups while chewing paraffin wax.
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment
Hide Description

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.”

Time Frame 1 day after orthodontic treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Ibuprofen Acetaminophen and Ibuprofen
Hide Arm/Group Description:

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

Acetaminophen: Acetaminophen gel capsule

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

Ibuprofen: Ibuprofen gel capsule

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

Acetaminophen: Acetaminophen gel capsule

Ibuprofen: Ibuprofen gel capsule

Overall Number of Participants Analyzed 7 8 7
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Rest 1.9  (2.5) 2.0  (1.7) 1.1  (1.2)
Biting 2.9  (2.5) 2.5  (2.1) 2.1  (2.7)
Chewing 3.6  (2.8) 3.9  (3.1) 2.7  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acetaminophen, Ibuprofen, Acetaminophen and Ibuprofen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments P-value for pain scores among the three comparison groups with jaw at rest.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Acetaminophen, Ibuprofen, Acetaminophen and Ibuprofen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments P-value for pain scores among the three comparison groups while lightly biting.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Acetaminophen, Ibuprofen, Acetaminophen and Ibuprofen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments P-value for pain scores among the three comparison groups while chewing paraffin wax.
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment
Hide Description

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.”

Time Frame 2 days after orthodontic treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Ibuprofen Acetaminophen and Ibuprofen
Hide Arm/Group Description:

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

Acetaminophen: Acetaminophen gel capsule

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

Ibuprofen: Ibuprofen gel capsule

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

Acetaminophen: Acetaminophen gel capsule

Ibuprofen: Ibuprofen gel capsule

Overall Number of Participants Analyzed 7 8 7
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Rest 1.3  (2.6) 1.4  (1.5) 0.4  (0.5)
Biting 2.3  (2.9) 2.3  (1.5) 0.9  (1.1)
Chewing 2.9  (2.9) 3.1  (2.0) 1.6  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acetaminophen, Ibuprofen, Acetaminophen and Ibuprofen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments P-value for pain scores among the three comparison groups with jaw at rest.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Acetaminophen, Ibuprofen, Acetaminophen and Ibuprofen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments P-value for pain scores among the three comparison groups while lightly biting.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Acetaminophen, Ibuprofen, Acetaminophen and Ibuprofen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments P-value for pain scores among the three comparison groups while chewing paraffin wax.
Method ANOVA
Comments [Not Specified]
Time Frame 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).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acetaminophen Ibuprofen Acetaminophen and Ibuprofen
Hide Arm/Group Description

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

Acetaminophen: Acetaminophen gel capsule

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

Ibuprofen: Ibuprofen gel capsule

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

Acetaminophen: Acetaminophen gel capsule

Ibuprofen: Ibuprofen gel capsule

All-Cause Mortality
Acetaminophen Ibuprofen Acetaminophen and Ibuprofen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/24 (0.00%)      0/25 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Acetaminophen Ibuprofen Acetaminophen and Ibuprofen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/24 (0.00%)      0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acetaminophen Ibuprofen Acetaminophen and Ibuprofen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/24 (0.00%)      1/25 (4.00%)    
General disorders       
Acute Headache *  0/24 (0.00%)  0 0/24 (0.00%)  0 1/25 (4.00%)  1
*
Indicates events were collected by non-systematic assessment
Low rate of participants returning results led to small number of participants analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Lead Investigator
Organization: University of Washington
Phone: 4254668544
EMail: akeith@uw.edu
Responsible Party: Andrew Keith, University of Washington
ClinicalTrials.gov Identifier: NCT03523988     History of Changes
Other Study ID Numbers: STUDY00001679
First Submitted: April 19, 2018
First Posted: May 14, 2018
Results First Submitted: August 3, 2018
Results First Posted: October 30, 2018
Last Update Posted: October 30, 2018