Dexamethasone and Etoricoxib for Pain Prevention Following Periodontal Surgery

This study has been completed.
Sponsor:
Information provided by:
Universidade Estadual de Ponta Grossa
ClinicalTrials.gov Identifier:
NCT00970112
First received: August 31, 2009
Last updated: May 17, 2010
Last verified: March 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

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

Primary Outcome Measures:
  • pain [ Time Frame: up to 3 days ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Gibson Luiz Pilatti, UEPG
ClinicalTrials.gov Identifier: NCT00970112     History of Changes
Other Study ID Numbers: 08169/08, 51/2008
Study First Received: August 31, 2009
Last Updated: May 17, 2010
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Etoricoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014