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NCT Number: NCT01948622

Anxiety Control by Erythrina Mulungu

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

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Key information

Conditions

Dental Anxiety Anxiety Disorders Impacted Third Molar Tooth Mental Disorders

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Federal University of Sergipe

Aracaju, Sergipe, 49060-100, Brazil

About this study

: 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%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mulungu

Drug

500 mg/single dose/1 hour before dental surgery

Other names: Mulungu Matusa, Erytrina mulungu

Placebo

Drug

500 mg/single dose/1 hour before dental surgery

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Liane Maciel de Almeida Souza

Other

Collaborators

  • University of Campinas, Brazil

Registry information

Official study title

Anxiety Control by Using Erythrina Mulungu in Mandibular Third Molars Extraction

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 23, 2013
Registry last updated
Sep 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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