Three Anxiolytic Drugs Used in Third Molar Surgery

Universidade Federal de Sergipe

Status and phase: Completed; Phase 3; Phase 2

Conditions: Impacted Third Molar Tooth; Dental Anxiety

Treatments: Drug: Passiflora incarnata; Drug: midazolam; Drug: Mulungu; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02065843

ANSI-388.427

Details and patient eligibility

About

This study was to compare the effectiveness of three drugs (Passiflora incarnata, Erythrina mulungum, Midazolam) 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, parallel study, 200 healthy volunteered patients aging 18 or older will be distributed into 4 groups (n=50) as follows: Group I - 500mg Erythrina mulungu; Group II - placebo; Group III ; 100 mg Passiflora incarnata; Group IV - 15 mg midazolam. All treatments will be administered p.o. 1 hour randomly prior to the surgical procedures. The level of anxiety will be assessed through questionnaires and physical parameters, such as blood pressure, heart rate and oxygen concentration in three periods: at baseline, right before the surgical procedures and after 7 days. Data will be 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: Parallel Assignment

Masking: Triple Blind

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30 participants in 4 patient groups, including a placebo group

Mulungu

Active Comparator group

Description:

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

Treatment:

Drug: Placebo

Passiflora incarnata

Active Comparator group

Description:

100 mg Passiflora incarnata (2 capsules of 50 mg) to be administered v.o., one hour before the surgical procedure.

Treatment:

Drug: Passiflora incarnata

midazolam

Active Comparator group

Description:

15 mg midazolam (2 capsules of 7.5 mg) to be administered v.o., one hour before the surgical procedure.

Treatment:

Drug: midazolam