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| Name | Class |
|---|---|
| University of Campinas, Brazil | OTHER |
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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.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mulungu | Active Comparator | 500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure. |
|
| placebo | Placebo Comparator | 500 mg of starch (2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure. |
|
| Passiflora incarnata | Active Comparator | 100 mg Passiflora incarnata (2 capsules of 50 mg) to be administered v.o., one hour before the surgical procedure. |
|
| midazolam | Active Comparator | 15 mg midazolam (2 capsules of 7.5 mg) to be administered v.o., one hour before the surgical procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mulungu | Drug | 500 mg/single dose/1 hour before dental surgery |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liane M Souza, PhD | Federal University of Sergipe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Sergipe | Aracaju | Sergipe | 49060-100 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19441926 | Background | Balbani AP, Silva DH, Montovani JC. Patents of drugs extracted from Brazilian medicinal plants. Expert Opin Ther Pat. 2009 Apr;19(4):461-73. doi: 10.1517/13543770902824180. | |
| 17268084 | Background | Flausino OA Jr, Pereira AM, da Silva Bolzani V, Nunes-de-Souza RL. Effects of erythrinian alkaloids isolated from Erythrina mulungu (Papilionaceae) in mice submitted to animal models of anxiety. Biol Pharm Bull. 2007 Feb;30(2):375-8. doi: 10.1248/bpb.30.375. |
| Label | URL |
|---|---|
| published article | View source |
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IPD will be kept not available
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 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 |
|
|
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 |
| D006571 | Heterocyclic Compounds |