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Dexamethasone and Etoricoxib for Pain Prevention Following Periodontal Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00970112
First Posted: September 2, 2009
Last Update Posted: May 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universidade Estadual de Ponta Grossa
  Purpose
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.

Condition Intervention Phase
Pain Control Procedure: Open Flap Debridement Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: O Uso de Dexametasona e Etoricoxibe Para a prevenção e Controle da Dor pós-operatória após Cirurgia Periodontal

Resource links provided by NLM:


Further study details as provided by Universidade Estadual de Ponta Grossa:

Primary Outcome Measures:
  • pain [ Time Frame: up to 3 days ]
    hourly for the 8 first hours after surgery 3 times a day on the following 3 days


Enrollment: 20
Study Start Date: November 2008
Study Completion Date: March 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970112


Locations
Brazil
UEPG
Ponta Grossa, Paraná, Brazil
Sponsors and Collaborators
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
  More Information

Responsible Party: Gibson Luiz Pilatti, UEPG
ClinicalTrials.gov Identifier: NCT00970112     History of Changes
Other Study ID Numbers: 08169/08
51/2008
First Submitted: August 31, 2009
First Posted: September 2, 2009
Last Update Posted: May 18, 2010
Last Verified: March 2010

Keywords provided by Universidade Estadual de Ponta Grossa:
pain
pain assessment

Additional relevant MeSH terms:
Etoricoxib
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents