Orthodontic PainPhase 4NCT00484744
Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement
A Phase 4 study testing Acetaminophen and Ibuprofen in people with Orthodontic Pain, run by University of Missouri, Kansas City at 2 sites in United States.
Trial summary
The purpose of this research study is to compare pain control effectiveness of two medicines and a placebo (a dummy pill that does not contain any pain relieving medication) to see which one works better at preventing pain when taken both 1 hour before and 6 hours after orthodontic separators are placed. Read more about this study
- Who is it for?
- Ages 9 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Pain
- What is being tested?
- Acetaminophen and Ibuprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2007to Jan 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 9 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Orthodontic treatment requires banding of posterior teeth
- Orthodontic treatment requires the placement of two or more separators
- Able to swallow analgesic pills
- English speaking
- Age 9-17
- Minimum weight requirement of 88 pounds
Who cannot join
- Orthodontic appliances are present in the mouth
- Use of acetaminophen or ibuprofen is contraindicated (allergy, GI problems)
- Antibiotics or analgesics are currently in use
- History of systemic disease exists (arthritis, diabetes, cystic fibrosis)
- Significant cognitive impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Orthodontic office of Drs. Dan Blackwell, Beth Blackwell-Nill, Scott Francois
Lee's Summit, Missouri, 64063
Orthodontic office of Dr. James Osborne
Lee's Summit, Missouri, 64082
About this study
The purpose of this research study is to compare pain control effectiveness of two medicines and a placebo (a dummy pill that does not contain any pain relieving medication) to see which one works better at preventing pain when taken both 1 hour before and 6 hours after orthodontic separators are placed. The research hypothesis is that there will be a significant difference in pain as measured by Visual Analogue Scales (VAS) over time and that this effect will differ for acetaminophen versus ibuprofen.
- Conditions
- Orthodontic Pain
- Being tested
- Acetaminophen, Avicel (placebo), Ibuprofen
- Keywords
- pain, orthodontic, acetaminophen, ibuprofen, separator
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Avicel (placebo)Drug
IbuprofenDrug
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen | Experimental | Not described Receives: Drug: Acetaminophen |
| Ibuprofen | Experimental | Not described Receives: Drug: Ibuprofen |
| Avicel | Placebo comparator | Not described Receives: Drug: Avicel (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain/discomfort levels reported on Visual Analogue Scales
Measured: Assessments conducted at six intervals during a 24 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic PainStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shelliann A Kawamoto, DDS, Principal investigator, University of Missouri-Kansas City School of Dentistry Department of Orthodontics and Dentofacial OrthopedicsKaren Williams, RDH, MS, PhD, Study chair, University of Missouri-Kansas City School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484744
- Sponsor's protocol ID
- 07 04-054
- Status last verified
- Aug 2020
- First submitted
- 7 Jun 2007
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement
- ClinicalTrials.gov ID
- NCT00484744
- Acronym / sponsor ID
- 07 04-054
- Conditions
- Orthodontic Pain
- Keywords
- pain, orthodontic, acetaminophen, ibuprofen, separator
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 11 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to compare pain control effectiveness of two medicines and a placebo (a dummy pill that does not contain any pain relieving medication) to see which one works better at preventing pain when taken both 1 hour before and 6 hours after orthodontic separators are placed. The research hypothesis is that there will be a significant difference in pain as measured by Visual Analogue Scales (VAS) over time and that this effect will differ for acetaminophen versus ibuprofen.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen | Experimental | Drug: Acetaminophen |
| Ibuprofen | Experimental | Drug: Ibuprofen |
| Avicel | Placebo comparator | Drug: Avicel (placebo) |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Orthodontic treatment requires banding of posterior teeth
- Orthodontic treatment requires the placement of two or more separators
- Able to swallow analgesic pills
- English speaking
- Age 9-17
Key exclusion criteria (5 listed)
- Orthodontic appliances are present in the mouth
- Use of acetaminophen or ibuprofen is contraindicated (allergy, GI problems)
- Antibiotics or analgesics are currently in use
- History of systemic disease exists (arthritis, diabetes, cystic fibrosis)
- Significant cognitive impairment
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 |
|---|---|---|
| Acetaminophen | Drug | Acetaminophen |
| Avicel (placebo) | Drug | Avicel |
| Ibuprofen | Drug | Ibuprofen |
Primary outcome
Pain/discomfort levels reported on Visual Analogue Scales
Time frame: Assessments conducted at six intervals during a 24 hour period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
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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.
Shelliann A Kawamoto, DDS principal investigator
University of Missouri-Kansas City School of Dentistry Department of Orthodontics and Dentofacial Orthopedics
Karen Williams, RDH, MS, PhD study chair
University of Missouri-Kansas City School of Dentistry
2 sites 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 Orthodontic Pain, run by University of Missouri, Kansas City at 2 sites 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 6 inclusion and 5 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 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain/discomfort levels reported on Visual Analogue Scales (time frame: Assessments conducted at six intervals during a 24 hour period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2020.