Acetaminophen Versus Ibuprofen for the Control of Immedia... | NCT00484744

Studies
Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement

NCT00484744

Sponsor

University of Missouri, Kansas City

Status

Completed

Last Update Posted

Aug 20, 2020Actual

Enrollment

35Actual

Phase

Phase 4

Conditions

Orthodontic Pain

Interventions

Acetaminophen
Avicel (placebo)
Ibuprofen

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2008Actual

First Submitted Date

Jun 7, 2007

First Submission Date that Met QC Criteria

Jun 7, 2007

First Posted Date

Jun 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2020

Last Update Posted Date

Aug 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Acetaminophen	Experimental	Drug: Acetaminophen
Ibuprofen	Experimental	Drug: Ibuprofen
Avicel	Placebo Comparator	Drug: Avicel (placebo)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acetaminophen	Drug		Acetaminophen
Avicel (placebo)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain/discomfort levels reported on Visual Analogue Scales		Assessments conducted at six intervals during a 24 hour period

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shelliann A Kawamoto, DDS	University of Missouri-Kansas City School of Dentistry Department of Orthodontics and Dentofacial Orthopedics	Principal Investigator
Karen Williams, RDH, MS, PhD	University of Missouri-Kansas City School of Dentistry	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orthodontic office of Drs. Dan Blackwell, Beth Blackwell-Nill, Scott Francois		Lee's Summit	Missouri	64063	United States

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000082	Acetaminophen
D002482	Cellulose
D007052	Ibuprofen

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided