Three Anxiolytic Drugs Used in Third Molar Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Anxiety; Impacted Third Molar Tooth
• Intervention / Treatment: Drug: Mulungu; Drug: Placebo; Drug: Passiflora incarnata; Drug: midazolam

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sergipe
    • Aracaju, Sergipe, Brazil, 49060-100
      • Federal University of Sergipe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / 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; Other Names: Mulungu Matusa, Erytrina mulungu
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; Other Names: Dormonid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in anxiety report	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.	Change from baseline to 7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidade Federal de Sergipe
• Collaborators: University of Campinas, Brazil
• Investigators: Principal Investigator: Liane M Souza, PhD, Federal University of Sergipe

Publications and helpful links

General Publications

• Balbani AP, Silva DH, Montovani JC. Patents of drugs extracted from Brazilian medicinal plants. Expert Opin Ther Pat. 2009 Apr;19(4):461-73. doi: 10.1517/13543770902824180.
• Flausino OA Jr, Pereira AM, da Silva Bolzani V, Nunes-de-Souza RL. Effects of erythrinian alkaloids isolated from Erythrina mulungu (Papilionaceae) in mice submitted to animal models of anxiety. Biol Pharm Bull. 2007 Feb;30(2):375-8. doi: 10.1248/bpb.30.375.

Helpful Links

• published article

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: February 15, 2014
• First Submitted That Met QC Criteria: February 15, 2014
• First Posted (Estimate): February 19, 2014

Study Record Updates

• Last Update Posted (Estimate): October 28, 2016
• Last Update Submitted That Met QC Criteria: October 26, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Anxiety; Blood pressure; Heart rate; Oxygen saturation; Third molar surgery
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: ANSI-388.427

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will be kept not available