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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03567369
• Other study ID #: 24042018
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 2, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: May 2018
• Source: Federal University of the Valleys of Jequitinhonha and Mucuri
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 17
• Est. completion date: October 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Molar, Third
• Surgery
• Trismus

Intervention

Drug:
• Dexamethasone
Dexamethasone 4,0 mg/mL
• Traumeel S
Traummel S 2,2 mg/mL

Locations

Country	Name	City	State
Brazil	Universidade Federal dos Vales do Jequitinhonha e Mucuri	Diamantina	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of the Valleys of Jequitinhonha and Mucuri

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to seven days postoperative