NCT02065843

Three Anxiolytic Drugs Used in Third Molar Surgery

Comparative Study of the Effectiveness of Three Anxiolytic Drugs Used in Third Molar Surgery

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Universidade Federal de Sergipe · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This study was to compare the effectiveness of three drugs (Passiflora incarnata, Erythrina mulungum, Midazolam) in controlling anxiety in patients undergoing bilateral extraction of asymptomatic, impacted mandibular third molars.

Detailed description

In this research, characterized as a randomized, double-blind, parallel study, 200 healthy volunteered patients aging 18 or older will be distributed into 4 groups (n=50) as follows: Group I - 500mg Erythrina mulungu; Group II - placebo; Group III ; 100 mg Passiflora incarnata; Group IV - 15 mg midazolam. All treatments will be administered p.o. 1 hour randomly prior to the surgical procedures. The level of anxiety will be assessed through questionnaires and physical parameters, such as blood pressure, heart rate and oxygen concentration in three periods: at baseline, right before the surgical procedures and after 7 days. Data will be collected, tabulated and analyzed by the following statistical tests: chi-square, t-test, ANOVA and Tukey test, Friedman, Fisher's exact test with significance level of 5%.

Conditions

• Dental Anxiety
• Impacted Third Molar Tooth

Interventions

Type	Name	Description
DRUG	Mulungu	500 mg/single dose/1 hour before dental surgery
DRUG	Placebo	500 mg/single dose/1 hour before dental surgery
DRUG	Passiflora incarnata	100 mg/single dose/1 hour before dental surgery
DRUG	midazolam	15 mg/single dose/1 hour before dental surgery

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-04-01
• Completion: 2014-09-01
• First posted: 2014-02-19
• Last updated: 2016-10-28

Locations

1 site across 1 country: Brazil