Anxiety Control by Erythrina Mulungu

Study Overview
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Brief Summary
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This study evaluated the effectiveness of the Erythrina mulungu 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, crossover study, 30 healthy volunteered patients (05 men and 25 women) aged 18 or older who received a capsule of 500mg of Mulungu Matusa ® or placebo, orally, one hour before the procedure were selected. The level of anxiety was assessed through questionnaires and physical parameters, such as blood pressure, heart rate and oxygen concentration. Data were 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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Anxiety Control by Using Erythrina Mulungu in Mandibular Third Molars Extraction

Conditions
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Dental Anxiety, Impacted Third Molar Tooth

Intervention / Treatment
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* Drug: Mulungu
* Drug: Placebo


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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mulungu<br>500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) 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) administered v.o., one hour before the surgical procedure. | Drug: Placebo<br>* 500 mg/single dose/1 hour before dental surgery<br>|

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 was 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) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing. | Change from baseline to 2 hours | 
| Changes in heart rate | heart rate (bpm) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing. | Change from baseline to 2 hours | 
| Changes in oxygen saturation | oxygen saturation (SpO2) was measured before drug administration, 30 minutes after drug 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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Anxiety, Third molar surgery, Blood pressure, Heart rate, Oxygen saturation