Comparison of the Use of Dexamethasone and Diclofenac Sodium in Immediate Post-Operative Care in Third Molar Surgery
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 3, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedMarch 3, 2016
February 1, 2016
1.1 years
February 9, 2016
February 28, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Pain assessed with a Visual Analog Scale
1 week
Swelling measured by an scale in mm
1 week
Mouth Opening measured by an scale in mm
1 week
Study Arms (2)
Dexamethasone
EXPERIMENTALDexamethasone: Dexametasone 4mg tablet every 8/8hs for 3 days
Diclofenac Sodium
ACTIVE COMPARATORDiclofenac Sodium: Diclofenac Sodium 50 mg tablet every 8/8 hs for 3 days
Interventions
Eligibility Criteria
You may qualify if:
- \- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Geral de Vila Penteado
São Paulo, São Paulo, 02802-120, Brazil
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fábio Ricardo L. Sato, PhD
Hospital Geral de Vila Penteado
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 9, 2016
First Posted
March 3, 2016
Study Start
February 1, 2015
Primary Completion
March 1, 2016
Study Completion
July 1, 2016
Last Updated
March 3, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share