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Anxiety Control by Erythrina Mulungu

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01948622
Recruitment Status : Completed
First Posted : September 23, 2013
Last Update Posted : September 23, 2013
Sponsor:
Collaborator:
University of Campinas, Brazil
Information provided by (Responsible Party):
Liane Maciel de Almeida Souza, Universidade Federal de Sergipe

Brief Summary:
This study evaluated the effectiveness of the Erythrina mulungu in controlling anxiety in patients undergoing bilateral extraction of asymptomatic, impacted mandibular third molars.

Condition or disease Intervention/treatment Phase
Dental Anxiety Impacted Third Molar Tooth Drug: Mulungu Drug: Placebo Phase 1 Phase 2

Detailed Description:
: In this research, characterized as a randomized, double-blind, crossover study, 30 healthy volunteered patients (05 men and 25 women) aged 18 or older who received a capsule of 500mg of Mulungu Matusa ® or placebo, orally, one hour before the procedure were selected. The level of anxiety was assessed through questionnaires and physical parameters, such as blood pressure, heart rate and oxygen concentration. Data were 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%.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anxiety Control by Using Erythrina Mulungu in Mandibular Third Molars Extraction
Study Start Date : January 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Mulungu
500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) 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) administered v.o., one hour before the surgical procedure.
Drug: Placebo
500 mg/single dose/1 hour before dental surgery




Primary Outcome Measures :
  1. Changes in anxiety report [ Time Frame: Change from baseline to 7 days ]
    Changes in the subjects' anxiety level was 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 :
  1. Changes in blood pressure [ Time Frame: Change from baseline to 2 hours ]
    blood pressure (mmHg) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing.

  2. Changes in heart rate [ Time Frame: Change from baseline to 2 hours ]
    heart rate (bpm) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing.

  3. Changes in oxygen saturation [ Time Frame: Change from baseline to 2 hours ]
    oxygen saturation (SpO2) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948622


Locations
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Brazil
Federal University of Sergipe
Aracaju, Sergipe, Brazil, 49060-100
Sponsors and Collaborators
Liane Maciel de Almeida Souza
University of Campinas, Brazil
Investigators
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Principal Investigator: Liane M Souza, PhD Federal University of Sergipe
Publications:
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Responsible Party: Liane Maciel de Almeida Souza, Assistant Professor, Universidade Federal de Sergipe
ClinicalTrials.gov Identifier: NCT01948622    
Other Study ID Numbers: Mulungu-401-2011
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: September 23, 2013
Last Verified: September 2013
Keywords provided by Liane Maciel de Almeida Souza, Universidade Federal de Sergipe:
Anxiety
Third molar surgery
Blood pressure
Heart rate
Oxygen saturation
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders