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Clinical Trials/NCT01948622
NCT01948622CompletedPhase 1

Anxiety Control by Using Erythrina Mulungu in Mandibular Third Molars Extraction

Liane Maciel de Almeida Souza1 site in 1 country30 target enrollmentStarted: January 2012Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Changes in anxiety report

Study Overview

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.

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%.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Mulungu

Active Comparator

500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) administered v.o., one hour before the surgical procedure.

Intervention: Mulungu (Drug)

placebo

Placebo Comparator

500 mg of starch (2 capsules of 250 mg) administered v.o., one hour before the surgical procedure.

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

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 Outcomes

  • Changes in oxygen saturation(Change from baseline to 2 hours)
  • Changes in blood pressure(Change from baseline to 2 hours)
  • Changes in heart rate(Change from baseline to 2 hours)

Investigators

Sponsor
Liane Maciel de Almeida Souza
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Liane Maciel de Almeida Souza

Assistant Professor

Universidade Federal de Sergipe

Study Sites (1)

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