Comparative Study of the Preoperative Efficacy of Traumeel Versus Dexamethasone in Control of Pain, Swelling and Trismus After Mandibular Third Molar Extractions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Postoperative sequelae following thir molar extraction
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dexamethasone
Dexamethasone 4,0 mg / mL
Intervention: Dexamethasone (Drug)
Traumeel S
Traumeel 2,2 mg / mL
Intervention: Traumeel S (Drug)
Outcomes
Primary Outcomes
Postoperative sequelae following thir molar extraction
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Marcos Luciano Pimenta Pinheiro
Principal Investigator
Federal University of the Valleys of Jequitinhonha and Mucuri