NCT00970112

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2009

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

May 18, 2010

Status Verified

March 1, 2010

Enrollment Period

10 months

First QC Date

August 31, 2009

Last Update Submit

May 17, 2010

Conditions

Pain Control

Keywords

painpain assessment

Outcome Measures

Primary Outcomes (1)

  • pain

    hourly for the 8 first hours after surgery 3 times a day on the following 3 days

    up to 3 days

Study Arms (3)

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

Open Flap DebridementPROCEDURE

Open flap debridement - access flap + scaling and root planning

DexamethaoneEtoricoxibPlacebo

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UEPG

Ponta Grossa, Paraná, Brazil

Location

MeSH Terms

Conditions

AgnosiaPain

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • João Paulo Steffens, MSc Student

    UEPG

    PRINCIPAL INVESTIGATOR

  • Fábio André Santos, PhD

    UEPG

    STUDY DIRECTOR

  • Gibson Luiz Pilatti, PhD

    UEPG

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 2, 2009

Study Start

November 1, 2008

Primary Completion

September 1, 2009

Study Completion

March 1, 2010

Last Updated

May 18, 2010

Record last verified: 2010-03

Locations

BR(1)