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

NCT03567369 — Not applicable, Unknown, 17 participants, Federal University of the Valleys of Jequitinhonha and Mucuri

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

Registry	NCT03567369
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: triple, treatment
Enrollment	17 (Estimated)
Sponsor	Federal University of the Valleys of Jequitinhonha and Mucuri (Other)
Conditions	Molar, Third, Surgery
Interventions	Dexamethasone, Traumeel S (Drug)
Dates	start 2018-04-02, primary completion 2018-07-31 (estimated), completion 2018-10-31 (estimated), first posted 2018-06-25, last updated 2018-06-25
Locations	1 site in Brazil

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Dexamethasone	Experimental	Drug: Dexamethasone	Dexamethasone 4,0 mg / mL
Traumeel S	Experimental	Drug: Traumeel S	Traumeel 2,2 mg / mL

Dexamethasone (Drug), also known as Dexamethasone Acetate, Decadron®: Dexamethasone 4,0 mg/mL
Traumeel S (Drug): Traummel S 2,2 mg/mL

+Outcome measures

Primary outcomes

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

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Universidade Federal dos Vales do Jequitinhonha e Mucuri	Diamantina, Minas Gerais	Brazil