92/5000 Preoperative Efficacy of Traumeel Versus Dexamethasone in the Control of Pain, Swelling and Trismus

NCT ID: NCT03567369

Last Updated: 2018-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-02

Study Completion Date

2018-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Molar, Third Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dexamethasone

Dexamethasone 4,0 mg / mL

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Dexamethasone 4,0 mg/mL

Traumeel S

Traumeel 2,2 mg / mL

Group Type EXPERIMENTAL

Traumeel S

Intervention Type DRUG

Traummel S 2,2 mg/mL

Interventions

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Dexamethasone

Dexamethasone 4,0 mg/mL

Intervention Type DRUG

Traumeel S

Traummel S 2,2 mg/mL

Intervention Type DRUG

Other Intervention Names

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Dexamethasone Acetate Decadron®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of the Valleys of Jequitinhonha and Mucuri

OTHER

Sponsor Role lead

Responsible Party

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Marcos Luciano Pimenta Pinheiro

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidade Federal dos Vales do Jequitinhonha e Mucuri

Diamantina, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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24042018

Identifier Type: -

Identifier Source: org_study_id

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