Last Verified: | September/30/2016 |
First Submitted: | February/14/2014 |
Estimated Enrollment Submitted: | February/14/2014 |
First Posted: | February/18/2014 |
Last Update Submitted: | October/25/2016 |
Last Update Posted: | October/27/2016 |
Actual Study Start Date: | February/28/2014 |
Estimated Primary Completion Date: | March/31/2014 |
Estimated Study Completion Date: | August/31/2014 |
Study Type: | Interventional |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Arm | Intervention/treatment |
---|---|
Active Comparator: Mulungu 500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure. | Drug: Mulungu 500 mg/single dose/1 hour before dental surgery |
Placebo Comparator: placebo 500 mg of starch (2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure. | Drug: placebo 500 mg/single dose/1 hour before dental surgery |
Active Comparator: Passiflora incarnata 100 mg Passiflora incarnata (2 capsules of 50 mg) to be administered v.o., one hour before the surgical procedure. | Drug: Passiflora incarnata 100 mg/single dose/1 hour before dental surgery |
Active Comparator: midazolam 15 mg midazolam (2 capsules of 7.5 mg) to be administered v.o., one hour before the surgical procedure. | Drug: midazolam 15 mg/single dose/1 hour before dental surgery |
Ages Eligible for Study: | 18 Years to 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria: | Inclusion Criteria: - indication of bilateral extraction of asymptomatic, impacted mandibular third molars Exclusion Criteria: - patients under the age of 18 any general health problem based on the medical history and physical examination history of use of any medication within 15 days before the beginning of the research history of hypersensitivity to drugs, substances or materials used in this experiment pregnancy or lactation history of pericoronitis |