Three Anxiolytic Drugs Used in Third Molar Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Universidade Federal de Sergipe
Sponsor:
Collaborator:
University of Campinas, Brazil
Information provided by (Responsible Party):
Liane Maciel de Almeida Souza, Universidade Federal de Sergipe
ClinicalTrials.gov Identifier:
NCT02065843
First received: February 15, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Dental Anxiety
Impacted Third Molar Tooth
Drug: Mulungu
Drug: Placebo
Drug: Passiflora incarnata
Drug: midazolam
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study of the Effectiveness of Three Anxiolytic Drugs Used in Third Molar Surgery

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Sergipe:

Primary Outcome Measures:
  • Changes in anxiety report [ Time Frame: Change from baseline to 7 days ] [ Designated as safety issue: No ]
    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:
  • Changes in blood pressure [ Time Frame: Change from baseline to 2 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    oxygen saturation (SpO2) will be measured before drugs administration, 30 minutes after drugs administration and during local anesthesia, incision, tooth removal and suturing.


Estimated Enrollment: 200
Study Start Date: March 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Dormonid

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%.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02065843

Contacts
Contact: Liane M Souza, PhD +557999777001 odontoliu@gmail.com
Contact: Francisco C Groppo, PhD +551921065310 fcgroppo@fop.unicamp.br

Locations
Brazil
Federal University of Sergipe Recruiting
Aracaju, Sergipe, Brazil, 49060-100
Principal Investigator: Liane M Souza, PhD         
Sponsors and Collaborators
Universidade Federal de Sergipe
University of Campinas, Brazil
Investigators
Principal Investigator: Liane M Souza, PhD Federal University of Sergipe
  More Information

Publications:
Responsible Party: Liane Maciel de Almeida Souza, Professor, Universidade Federal de Sergipe
ClinicalTrials.gov Identifier: NCT02065843     History of Changes
Other Study ID Numbers: ANSI-388.427
Study First Received: February 15, 2014
Last Updated: February 15, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal de Sergipe:
Anxiety
Third molar surgery
Blood pressure
Heart rate
Oxygen saturation

Additional relevant MeSH terms:
Tooth, Impacted
Anxiety Disorders
Mental Disorders
Tooth Diseases
Stomatognathic Diseases
Midazolam
Anti-Anxiety Agents
Tranquilizing Agents
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014