Dexamethasone and Etoricoxib for Pain Prevention Following Periodontal Surgery

May 17, 2010 updated by: Universidade Estadual de Ponta Grossa

O Uso de Dexametasona e Etoricoxibe Para a prevenção e Controle da Dor pós-operatória após Cirurgia Periodontal

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraná
      • Ponta Grossa, Paraná, Brazil
        • UEPG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Placebo 1 hour before surgery
Procedure: Open Flap Debridement
Open flap debridement - access flap + scaling and root planning
EXPERIMENTAL: Etoricoxib
Etoricoxib 1 hour before surgery
Procedure: Open Flap Debridement
Open flap debridement - access flap + scaling and root planning
EXPERIMENTAL: Dexamethaone
Dexamethasone 1 hour before surgery
Procedure: Open Flap Debridement
Open flap debridement - access flap + scaling and root planning

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Estadual de Ponta Grossa

Investigators

  • Principal Investigator: João Paulo Steffens, MSc Student, UEPG
  • Study Director: Fábio André Santos, PhD, UEPG
  • Study Chair: Gibson Luiz Pilatti, PhD, UEPG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

August 31, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (ESTIMATE)

September 2, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 18, 2010

Last Update Submitted That Met QC Criteria

May 17, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 08169/08
  • 51/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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