Three Anxiolytic Drugs Used in Third Molar Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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%.

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

Conditions
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Dental Anxiety, Impacted Third Molar Tooth

Intervention / Treatment
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* Drug: Mulungu
* Drug: Placebo
* Drug: Passiflora incarnata
* Drug: midazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mulungu<br>500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure. | Drug: Mulungu<br>* 500 mg/single dose/1 hour before dental surgery<br>* Other names: Mulungu Matusa, Erytrina mulungu;|
| Placebo Comparator: placebo<br>500 mg of starch (2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure. | Drug: Placebo<br>* 500 mg/single dose/1 hour before dental surgery<br>|
| Active Comparator: Passiflora incarnata<br>100 mg Passiflora incarnata (2 capsules of 50 mg) to be administered v.o., one hour before the surgical procedure. | Drug: Passiflora incarnata<br>* 100 mg/single dose/1 hour before dental surgery<br>|
| Active Comparator: midazolam<br>15 mg midazolam (2 capsules of 7.5 mg) to be administered v.o., one hour before the surgical procedure. | Drug: midazolam<br>* 15 mg/single dose/1 hour before dental surgery<br>* Other names: Dormonid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Change from baseline to 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxygen saturation, Anxiety, Third molar surgery, Blood pressure, Heart rate