Three Anxiolytic Drugs Used in Third Molar Surgery

Phase 2

Completed

• Conditions: Impacted Third Molar Tooth; Dental Anxiety
• Interventions: Drug: Passiflora incarnata; Drug: Placebo; Drug: midazolam; Drug: Mulungu

• Registration Number: NCT02065843
• Lead Sponsor: Universidade Federal de Sergipe

Brief 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%.

Study Timeline

• Study First Submitted: 2014-02-15
• Study First Submitted QC: 2014-02-15
• Study First Posted: 2014-02-19
• Study Start: 2014-03
• Primary Completion: 2014-04
• Study Completion: 2014-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Passiflora incarnata	Passiflora incarnata	100 mg Passiflora incarnata (2 capsules of 50 mg) to be administered v.o., one hour before the surgical procedure.
placebo	Placebo	500 mg of starch (2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure.
midazolam	midazolam	15 mg midazolam (2 capsules of 7.5 mg) to be administered v.o., one hour before the surgical procedure.
Mulungu	Mulungu	500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure.

Primary Outcome Measures

Name	Time	Method
Changes in anxiety report	Change from baseline to 7 days	Changes in the subjects' anxiety level will be observed by using a Modified Corah Dental Anxiety Scale in three times: at baseline, in the day of surgery and after 7 days of the procedure.

Secondary Outcome Measures

Name	Time	Method
Changes in blood pressure	Change from baseline to 2 hours	blood pressure (mmHg) will be measured before the drugs administration, 30 minutes after drugs administration and during local anesthesia, incision, tooth removal and suturing.
Changes in heart rate	Change from baseline to 2 hours	heart rate (bpm) will be measured before drugs administration, 30 minutes after drugs administration and during local anesthesia, incision, tooth removal and suturing.
Changes in oxygen saturation	Change from baseline to 2 hours	oxygen saturation (SpO2) will be measured before drugs administration, 30 minutes after drugs administration and during local anesthesia, incision, tooth removal and suturing.

Trial Locations

Locations (1)

Federal University of Sergipe; 🇧🇷 Aracaju, Sergipe, Brazil