Three Anxiolytic Drugs Used in Third Molar Surgery

Overview

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.

Full Title of Study: “Comparative Study of the Effectiveness of Three Anxiolytic Drugs Used in Third Molar Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2014

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%.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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.
  • Placebo Comparator: placebo
    • 500 mg of starch (2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure.
  • Active Comparator: Passiflora incarnata
    • 100 mg Passiflora incarnata (2 capsules of 50 mg) to be administered v.o., one hour before the surgical procedure.
  • Active Comparator: midazolam
    • 15 mg midazolam (2 capsules of 7.5 mg) to be administered v.o., one hour before the surgical procedure.

Clinical Trial Outcome Measures

Primary Measures

  • Changes in anxiety report
    • Time Frame: 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 Measures

  • Changes in blood pressure
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universidade Federal de Sergipe
  • Collaborator
    • University of Campinas, Brazil
  • Provider of Information About this Clinical Study
    • Principal Investigator: Liane Maciel de Almeida Souza, Professor – Universidade Federal de Sergipe
  • Overall Official(s)
    • Liane M Souza, PhD, Principal Investigator, Federal University of Sergipe

References

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.