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Comparison of the Use of Dexamethasone and Diclofenac Sodium in Immediate Post-Operative Care in Third Molar Surgery

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ClinicalTrials.gov Identifier: NCT02698306
Recruitment Status : Unknown
Verified February 2016 by Fábio Ricardo Loureiro Sato, Hospital Geral de Vila Penteado.
Recruitment status was:  Recruiting
First Posted : March 3, 2016
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
Fábio Ricardo Loureiro Sato, Hospital Geral de Vila Penteado

Brief Summary:
The investigators will select 30 patients with symmetrical impaction of third molars, according to Pell and Gregory dental impaction classification, who would be submitted to two surgical procedures, right and left, and in both surgeries dexamethasone 8 mg was administered in the pre-surgery phase, and the use of dexamethasone (12 mg/day) for 3 days on one side and diclofenac sodium (150 mg/day) for 3 days on the other side was continued, in a randomized, double-blind and cross-over trial so that all patients acted as control of themselves (split-mouth). Other drugs used in postoperative period, rescue analgesic and antibiotic therapy will be identical for all patients. The analyzed variables will be the visual analogue pain scale (VAS), total number of consumed analgesics, swelling and trismus (objectively), which were statistically analyzed by means of Student's t-test.

Condition or disease Intervention/treatment Phase
Impacted Third Molar Tooth Drug: Dexamethasone Drug: Diclofenac Sodium Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Use of Dexamethasone and Diclofenac Sodium in Immediate Post-Operative Care in Third Molar Surgery
Study Start Date : February 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : July 2016


Arm Intervention/treatment
Experimental: Dexamethasone
Dexamethasone: Dexametasone 4mg tablet every 8/8hs for 3 days
Drug: Dexamethasone
Dexamethasone
Other Name: Decadron

Active Comparator: Diclofenac Sodium
Diclofenac Sodium: Diclofenac Sodium 50 mg tablet every 8/8 hs for 3 days
Drug: Diclofenac Sodium
Diclofenac Sodium
Other Name: Voltarem




Primary Outcome Measures :
  1. Pain assessed with a Visual Analog Scale [ Time Frame: 1 week ]
  2. Swelling measured by an scale in mm [ Time Frame: 1 week ]
  3. Mouth Opening measured by an scale in mm [ Time Frame: 1 week ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Patients had to have four third molars indicating the need for extraction and in any position of impact, as long as there was symmetry between the two sides.

Exclusion Criteria:

  • Patients with a history of alcoholism, drug use, antihistamine drugs, antidepressants, cimetidine or any drug that could interfere with the painful sensitivity of the patient.
  • Patients with systemic disorders such as diabetes, hypertension, heart disease, allergy to any component of the formula, sulfa drugs and also pregnant women, nursing mothers, persons experiencing dental fear and children were excluded.
  • Patients who had pericoronitis and/or radiolucent images associated with the teeth to be extracted

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): NCT02698306


Contacts
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Contact: Fábio Ricardo L Sato, PhD 55 11 98292 2294 frlsato@uol.com.br

Locations
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Brazil
Hospital Geral de Vila Penteado Recruiting
São Paulo, Brazil, 02802-120
Contact: Fábio Ricardo L Sato, PhD    55 11 98292 2294    frlsato@uol.com.br   
Principal Investigator: Fábio Ricardo L Sato, PhD         
Sponsors and Collaborators
Hospital Geral de Vila Penteado
Investigators
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Principal Investigator: Fábio Ricardo L. Sato, PhD Hospital Geral de Vila Penteado

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Responsible Party: Fábio Ricardo Loureiro Sato, Principal Investigator, Hospital Geral de Vila Penteado
ClinicalTrials.gov Identifier: NCT02698306     History of Changes
Other Study ID Numbers: HospitalGVP
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diclofenac
Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors