Anxiety Control by Erythrina Mulungu

Liane Maciel de Almeida Souza

Status and phase: Completed; Phase 2; Phase 1

Conditions: Impacted Third Molar Tooth; Dental Anxiety

Treatments: Drug: Placebo; Drug: Mulungu

Study type: Interventional

Funder types: Other

Identifiers

NCT01948622

Mulungu-401-2011

Details and patient eligibility

About

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

Full 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%.

Enrollment: 30 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Mulungu

Active Comparator group

Description:

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

Treatment:

Drug: Mulungu

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo