Back to results92/5000 Preoperative Efficacy of Traumeel Versus Dexamethasone in the Control of Pain, Swelling and Trismus
Primary Purpose
Molar, Third, Surgery
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dexamethasone
Traumeel S
Sponsored by
About this trial
This is an interventional treatment trial for Molar, Third focused on measuring Third molar, Surgery, Swelling
Eligibility Criteria
Inclusion Criteria:
- Patients with indication of asymptomatic bilateral extractions of lower third molars;
- Aged 18 years or older;
- Have a good health and no disease.
Exclusion Criteria:
• Patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation
Sites / Locations
- Universidade Federal dos Vales do Jequitinhonha e Mucuri
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dexamethasone
Traumeel S
Arm Description
Dexamethasone 4,0 mg / mL
Traumeel 2,2 mg / mL
Outcomes
Primary Outcome Measures
Postoperative sequelae following thir molar extraction
During the postoperative intervals of 24, 48 and 72 hours and seven days, the swelling was determined using linear measures in the face and trismus by maximum mouth opening. The postoperative pain was self-recorded by the patient using visual analogue scale in 72 hours with an interval of eight hours
Secondary Outcome Measures
Full Information
NCT ID
NCT03567369
First Posted
May 14, 2018
Last Updated
June 12, 2018
Sponsor
Federal University of the Valleys of Jequitinhonha and Mucuri
1. Study Identification
Unique Protocol Identification Number
NCT03567369
Brief Title
92/5000 Preoperative Efficacy of Traumeel Versus Dexamethasone in the Control of Pain, Swelling and Trismus
Official Title
Comparative Study of the Preoperative Efficacy of Traumeel Versus Dexamethasone in Control of Pain, Swelling and Trismus After Mandibular Third Molar Extractions
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Anticipated)
Study Completion Date
October 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of the Valleys of Jequitinhonha and Mucuri
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare the efficacy of intramuscular injection of two anti-inflammatory drugs, Traumeel and Dexamethasone, used in the control of postoperative complications pain, edema and trismus after third molar extraction mandibular
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molar, Third, Surgery
Keywords
Third molar, Surgery, Swelling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Dexamethasone 4,0 mg / mL
Arm Title
Traumeel S
Arm Type
Experimental
Arm Description
Traumeel 2,2 mg / mL
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Dexamethasone Acetate, Decadron®
Intervention Description
Dexamethasone 4,0 mg/mL
Intervention Type
Drug
Intervention Name(s)
Traumeel S
Intervention Description
Traummel S 2,2 mg/mL
Primary Outcome Measure Information:
Title
Postoperative sequelae following thir molar extraction
Description
During the postoperative intervals of 24, 48 and 72 hours and seven days, the swelling was determined using linear measures in the face and trismus by maximum mouth opening. The postoperative pain was self-recorded by the patient using visual analogue scale in 72 hours with an interval of eight hours
Time Frame
up to seven days postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with indication of asymptomatic bilateral extractions of lower third molars;
Aged 18 years or older;
Have a good health and no disease.
Exclusion Criteria:
• Patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation
Facility Information:
Facility Name
Universidade Federal dos Vales do Jequitinhonha e Mucuri
City
Diamantina
State/Province
Minas Gerais
ZIP/Postal Code
39100000
Country
Brazil
12. IPD Sharing Statement
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92/5000 Preoperative Efficacy of Traumeel Versus Dexamethasone in the Control of Pain, Swelling and Trismus
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