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Dexamethasone and Etoricoxib for Pain Prevention Following Periodontal Surgery

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ClinicalTrials.gov Identifier: NCT00970112
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : May 18, 2010
Sponsor:
Information provided by:
Universidade Estadual de Ponta Grossa

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.

Condition or disease Intervention/treatment Phase
Pain Control Procedure: Open Flap Debridement Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : November 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


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




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



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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

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

Responsible Party: Gibson Luiz Pilatti, UEPG
ClinicalTrials.gov Identifier: NCT00970112     History of Changes
Other Study ID Numbers: 08169/08
51/2008
First Posted: September 2, 2009    Key Record Dates
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