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NCT Number: NCT02065843

Three Anxiolytic Drugs Used in Third Molar Surgery

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.

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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 2 / Phase 3

Primary location

Federal University of Sergipe

Aracaju, Sergipe, 49060-100, Brazil

About this study

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%.

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

Passiflora incarnata

Drug

100 mg/single dose/1 hour before dental surgery

midazolam

Drug

15 mg/single dose/1 hour before dental surgery

Other names: Dormonid

Primary outcomes

  1. Changes in anxiety report

    Time frame: Change from baseline to 7 days

    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.

Secondary outcomes

  1. Changes in blood pressure

    Time frame: Change from baseline to 2 hours

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

Sponsors and collaborators

Lead sponsor

Universidade Federal de Sergipe

Other

Collaborators

  • University of Campinas, Brazil

Registry information

Official study title

Comparative Study of the Effectiveness of Three Anxiolytic Drugs Used in Third Molar Surgery

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 19, 2014
Registry last updated
Oct 28, 2016

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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