NSAIDPhase 4NCT03523988

Pre-emptive Analgesics in Orthodontic Treatment

A Phase 4 study testing Acetaminophen and Ibuprofen in people with NSAID and Pain Management, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 59 yearsHealthy volunteers can take part
Conditions the study is for: NSAID, Pain Management
What is being tested?: Acetaminophen and Ibuprofen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 73 participants
Where: 1 siteUnited States
Study dates: 2 May 2017to 1 Aug 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 59 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

-Orthodontic patient presenting for orthodontic treatment

Who cannot join

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

Show all 9Show fewer

Currently taking antibiotics or other medications for a chronic systemic disease
Bleeding disorder
Pregnant or nursing

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington
Seattle, Washington, 98195

Other trials in United States

About this study

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

Read the 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.

Conditions: NSAID, Pain Management
Being tested: Acetaminophen, Ibuprofen
Keywords: Pre-emptive analgesics, Acetaminophen, Ibuprofen
Medical subject headings: Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcetaminophenDrug
Also called Tylenol, Paracetamol
Acetaminophen gel capsule
IbuprofenDrug
Also called Advil
Ibuprofen gel capsule

Study groups in NCT03523988
Study group	Role	What they receive
Acetaminophen	Active comparator	Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment Receives: Drug: Acetaminophen
Ibuprofen	Active comparator	Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Receives: Drug: Ibuprofen
Acetaminophen and Ibuprofen	Experimental	Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Receives: Drug: Acetaminophen; Drug: Ibuprofen

What is being measured

The primary outcome is the main question the study is designed to answer.

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."
Measured: 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."
Measured: 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."
Measured: 2 days after orthodontic treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 May 20171 Aug 2017

First posted14 May 2018
Study start2 May 2017
Primary completion23 Jun 2017
Study completion1 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NSAIDStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients of the University of Washington Graduate Orthodontics Clinic
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03523988
Sponsor's protocol ID: STUDY00001679
Status last verified: Aug 2019
First submitted: 19 Apr 2018
Last updated: 21 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Pre-emptive Use of Combined Ibuprofen and Acetaminophen on Pain Control in Orthodontic Treatment
ClinicalTrials.gov ID: NCT03523988
Acronym / sponsor ID: STUDY00001679
Conditions: NSAID, Pain Management
Keywords: Pre-emptive analgesics, Acetaminophen, Ibuprofen
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Study start: 2 May 2017 (actual)
Primary completion: 23 Jun 2017 (actual)
Study completion: 1 Aug 2017 (actual)
First posted: 14 May 2018 (actual)
Results: Posted 30 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3
Model description: Patients of the University of Washington Graduate Orthodontics Clinic

Arm	Type	Receives
Acetaminophen	Active comparator	Drug: AcetaminophenAcetaminophen 650mg powder in gel capsule taken by mouth before entering appointment
Ibuprofen	Active comparator	Drug: IbuprofenIbuprofen 400mg powder in gel capsule taken by mouth before entering appointment
Acetaminophen and Ibuprofen	Experimental	Drug: Acetaminophen, Drug: IbuprofenAcetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment

Who may qualify

Ages: 12 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

-Orthodontic patient presenting for orthodontic treatment

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AcetaminophenAlso: Tylenol, ParacetamolAcetaminophen gel capsule	Drug	Acetaminophen, Acetaminophen and Ibuprofen
IbuprofenAlso: AdvilIbuprofen gel capsule	Drug	Acetaminophen and Ibuprofen, Ibuprofen

Primary outcome

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."

Results and safety

Results posted to the registry on 30 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acetaminophen	24	7
Ibuprofen	24	8
Acetaminophen and Ibuprofen	25	7

Primary outcome: Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment

Time frame: 6 hours after orthodontic treatment. Mean (Standard Deviation). Unit: scores on a scale

Measure	Acetaminophen n = 7	Ibuprofen n = 8	Acetaminophen and Ibuprofen n = 7
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)

Acetaminophen vs Ibuprofen vs Acetaminophen and Ibuprofen: p = 0.04, ANOVA
Acetaminophen vs Ibuprofen vs Acetaminophen and Ibuprofen: p = 0.63, ANOVA
Acetaminophen vs Ibuprofen vs Acetaminophen and Ibuprofen: p = 0.41, ANOVA

Primary outcome: Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment

Time frame: 1 day after orthodontic treatment. Mean (Standard Deviation). Unit: scores on a scale

Measure	Acetaminophen n = 7	Ibuprofen n = 8	Acetaminophen and Ibuprofen n = 7
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)

Acetaminophen vs Ibuprofen vs Acetaminophen and Ibuprofen: p = 0.65, ANOVA
Acetaminophen vs Ibuprofen vs Acetaminophen and Ibuprofen: p = 0.82, ANOVA
Acetaminophen vs Ibuprofen vs Acetaminophen and Ibuprofen: p = 0.69, ANOVA

Primary outcome: Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment

Time frame: 2 days after orthodontic treatment. Mean (Standard Deviation). Unit: scores on a scale

Measure	Acetaminophen n = 7	Ibuprofen n = 8	Acetaminophen and Ibuprofen n = 7
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)

Acetaminophen vs Ibuprofen vs Acetaminophen and Ibuprofen: p = 0.53, ANOVA
Acetaminophen vs Ibuprofen vs Acetaminophen and Ibuprofen: p = 0.31, ANOVA
Acetaminophen vs Ibuprofen vs Acetaminophen and Ibuprofen: p = 0.37, ANOVA

Adverse events

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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acetaminophen	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Ibuprofen	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Acetaminophen and Ibuprofen	0 of 25 (0%)	1 of 25 (4%)	0 of 25

Limitations and caveats (from the sponsor): Low rate of participants returning results led to small number of participants analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anne-Marie Bollen, DDS, MS, PhD study director

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Acetaminophen and Ibuprofen in people with NSAID and Pain Management, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment (time frame: 6 hours after orthodontic treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03523988.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.