Anxiety Control by Erythrina Mulungu

Phase 1

Completed

• Conditions: Dental Anxiety; Impacted Third Molar Tooth
• Interventions: Drug: Mulungu; Drug: Placebo

• Registration Number: NCT01948622
• Lead Sponsor: Liane Maciel de Almeida Souza

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 Timeline

• Study Start: 2012-01
• Primary Completion: 2012-06
• Study Completion: 2012-11
• Status Verified: 2013-09
• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-18
• Last Update Submitted: 2013-09-18
• Study First Posted: 2013-09-23
• Last Update Posted: 2013-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Changes in anxiety report	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

Name	Time	Method
Changes in oxygen saturation	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.
Changes in blood pressure	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.
Changes in heart rate	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.

Trial Locations

Locations (1)

Federal University of Sergipe; 🇧🇷 Aracaju, Sergipe, Brazil