Three Anxiolytic Drugs Used in Third Molar Surgery

Phase 3CompletedNCT02065843

Universidade Federal de Sergipe30 enrolled

Overview

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.

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%.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Dental Anxiety Impacted Third Molar Tooth

Interventions

MulunguDRUG

500 mg/single dose/1 hour before dental surgery

PlaceboDRUG

500 mg/single dose/1 hour before dental surgery

Passiflora incarnataDRUG

100 mg/single dose/1 hour before dental surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Federal University of Sergipe

Aracaju, Sergipe, Brazil

Outcomes

Primary Outcomes

Changes in anxiety report

Changes in the subjects' anxiety level will be 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.

Time frame: Change from baseline to 7 days

Secondary Outcomes

Changes in blood pressure

blood pressure (mmHg) will be measured before the drugs administration, 30 minutes after drugs administration and during local anesthesia, incision, tooth removal and suturing.

Time frame: Change from baseline to 2 hours

Changes in heart rate

heart rate (bpm) will be measured before drugs administration, 30 minutes after drugs administration and during local anesthesia, incision, tooth removal and suturing.

Time frame: Change from baseline to 2 hours

Changes in oxygen saturation

oxygen saturation (SpO2) will be measured before drugs administration, 30 minutes after drugs administration and during local anesthesia, incision, tooth removal and suturing.

Time frame: Change from baseline to 2 hours

Data from ClinicalTrials.gov

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