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

Sponsor

Federal University of the Valleys of Jequitinhonha and Mucuri (Other)

Overall Status

Unknown status

CT.gov ID

NCT03567369

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Molar, Third Surgery	Drug: Dexamethasone Drug: Traumeel S	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparative Study of the Preoperative Efficacy of Traumeel Versus Dexamethasone in Control of Pain, Swelling and Trismus After Mandibular Third Molar Extractions

Actual Study Start Date :

Apr 2, 2018

Anticipated Primary Completion Date :

Jul 31, 2018

Anticipated Study Completion Date :

Oct 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexamethasone Dexamethasone 4,0 mg / mL	Drug: Dexamethasone Dexamethasone 4,0 mg/mL Other Names: Dexamethasone Acetate Decadron®
Experimental: Traumeel S Traumeel 2,2 mg / mL	Drug: Traumeel S Traummel S 2,2 mg/mL

Arm

Intervention/Treatment

Experimental: Dexamethasone

Dexamethasone 4,0 mg / mL

Drug: Dexamethasone

Dexamethasone 4,0 mg/mL

Other Names:

Dexamethasone Acetate

Decadron®

Experimental: Traumeel S

Traumeel 2,2 mg / mL

Drug: Traumeel S

Traummel S 2,2 mg/mL

Outcome Measures

Primary Outcome Measures

Postoperative sequelae following thir molar extraction [up to seven days postoperative]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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