Dexamethasone and Etoricoxib for Pain Prevention Followin... | NCT00970112

Studies
Dexamethasone and Etoricoxib for Pain Prevention Following Periodontal Surgery

NCT00970112

Sponsor

Universidade Estadual de Ponta Grossa

Status

Completed

Last Update Posted

May 18, 2010Estimated

Enrollment

20Actual

Phase

Phase 2Phase 3

Conditions

Pain Control

Interventions

Open Flap Debridement

Countries

Brazil

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

ID	Type	Description	Link
51/2008

Status Module

Record Verification Date

Mar 2010

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

Nov 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Mar 2010Actual

First Submitted Date

Aug 31, 2009

First Submission Date that Met QC Criteria

Sep 1, 2009

First Posted Date

Sep 2, 2009Estimated

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

May 17, 2010

Last Update Posted Date

May 18, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 study is to investigate whether preemptive medication with dexamethasone or etoricoxib provides better pain management and control than placebo following periodontal surgery.

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo 1 hour before surgery	Procedure: Open Flap Debridement
Etoricoxib	Experimental	Etoricoxib 1 hour before surgery	Procedure: Open Flap Debridement
Dexamethaone	Experimental	Dexamethasone 1 hour before surgery	Procedure: Open Flap Debridement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Open Flap Debridement	Procedure	Open flap debridement - access flap + scaling and root planning	Dexamethaone Etoricoxib Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain	hourly for the 8 first hours after surgery 3 times a day on the following 3 days	up to 3 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients presenting moderate or severe periodontitis after nonsurgical periodontal treatment with clinical signs of inflammation

Exclusion Criteria:

Pregnant
Diabetes mellitus
Heart diseases
Allergic to components of the medications
Risk of endocarditis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
João Paulo Steffens, MSc Student	UEPG	Principal Investigator
Fábio André Santos, PhD	UEPG	Study Director
Gibson Luiz Pilatti, PhD	UEPG	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UEPG		Ponta Grossa	Paraná		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia
D010146	Pain

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided