Three Anxiolytic Drugs Used in Third Molar Surgery
Status:
Completed
Sponsors
Universidade Federal de Sergipe
Collaborators
University of Campinas, Brazil
Abstract:
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.
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%.
Last Verified:September/30/2016
First Submitted:February/14/2014
Estimated Enrollment Submitted:February/14/2014
First Posted:February/18/2014
Last Update Submitted:October/25/2016
Last Update Posted:October/27/2016
Actual Study Start Date:February/28/2014
Estimated Primary Completion Date:March/31/2014
Estimated Study Completion Date:August/31/2014
Condition or disease:Dental Anxiety
Impacted Third Molar Tooth
Intervention/treatment:
Drug: Mulungu
Drug: placebo
Drug: Passiflora incarnata
Drug: midazolam
Phase:Phase 2/Phase 3
Study design:
Study Type:Interventional
Allocation:Randomized
Primary Purpose:Treatment
Masking:Triple (Participant, Investigator, Outcomes Assessor)
Arm group:
ArmIntervention/treatment
Active Comparator: Mulungu
500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure.
Drug: Mulungu
500 mg/single dose/1 hour before dental surgery
Placebo Comparator: placebo
500 mg of starch (2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure.
Drug: placebo
500 mg/single dose/1 hour before dental surgery
Active Comparator: Passiflora incarnata
100 mg Passiflora incarnata (2 capsules of 50 mg) to be administered v.o., one hour before the surgical procedure.
Drug: Passiflora incarnata
100 mg/single dose/1 hour before dental surgery
Active Comparator: midazolam
15 mg midazolam (2 capsules of 7.5 mg) to be administered v.o., one hour before the surgical procedure.
Drug: midazolam
15 mg/single dose/1 hour before dental surgery
Eligibility Criteria:
Ages Eligible for Study:18 Years to 18 Years
Sexes Eligible for Study:All
Accepts Healthy Volunteers:Yes
Criteria:

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

Outcome:
Primary Outcome Measures
1. Changes in anxiety report [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 Outcome Measures
1. Changes in blood pressure [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 [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 [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.
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