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Anxiety Control by Erythrina Mulungu

Primary Purpose

Dental Anxiety, Impacted Third Molar Tooth

Status

Completed

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

Mulungu

Placebo

About this trial

This is an interventional treatment trial for Dental Anxiety focused on measuring Anxiety, Third molar surgery, Blood pressure, Heart rate, Oxygen saturation

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Federal University of Sergipe

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Mulungu

placebo

Arm Description

500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) administered v.o., one hour before the surgical procedure.

500 mg of starch (2 capsules of 250 mg) administered v.o., one hour before the surgical procedure.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT01948622

First Posted

September 10, 2013

Last Updated

September 18, 2013

Sponsor

Liane Maciel de Almeida Souza

Collaborators

University of Campinas, Brazil

1. Study Identification

Unique Protocol Identification Number

NCT01948622

Brief Title

Anxiety Control by Erythrina Mulungu

Official Title

Anxiety Control by Using Erythrina Mulungu in Mandibular Third Molars Extraction

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Liane Maciel de Almeida Souza

Collaborators

University of Campinas, Brazil

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

: 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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Anxiety, Impacted Third Molar Tooth

Keywords

Anxiety, Third molar surgery, Blood pressure, Heart rate, Oxygen saturation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mulungu

Arm Type

Active Comparator

Arm Description

500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) administered v.o., one hour before the surgical procedure.

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

500 mg of starch (2 capsules of 250 mg) administered v.o., one hour before the surgical procedure.

Intervention Type

Drug

Intervention Name(s)

Mulungu

Other Intervention Name(s)

Mulungu Matusa, Erytrina mulungu

Intervention Description

500 mg/single dose/1 hour before dental surgery

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

500 mg/single dose/1 hour before dental surgery

Primary Outcome Measure Information:

Title

Changes in anxiety report

Description

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.

Time Frame

Change from baseline to 7 days

Secondary Outcome Measure Information:

Title

Changes in blood pressure

Description

blood pressure (mmHg) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing.

Time Frame

Change from baseline to 2 hours

Title

Changes in heart rate

Description

heart rate (bpm) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing.

Time Frame

Change from baseline to 2 hours

Title

Changes in oxygen saturation

Description

oxygen saturation (SpO2) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing.

Time Frame

Change from baseline to 2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liane M Souza, PhD

Organizational Affiliation

Federal University of Sergipe

Official's Role

Principal Investigator

Facility Information:

Facility Name

Federal University of Sergipe

City

Aracaju

State/Province

Sergipe

ZIP/Postal Code

49060-100

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

19441926

Citation

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.

Results Reference

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PubMed Identifier

17268084

Citation

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.

Results Reference

background

PubMed Identifier

17253849

Citation

Flausino O Jr, Santos Lde A, Verli H, Pereira AM, Bolzani Vda S, Nunes-de-Souza RL. Anxiolytic effects of erythrinian alkaloids from Erythrina mulungu. J Nat Prod. 2007 Jan;70(1):48-53. doi: 10.1021/np060254j.

Results Reference

background

PubMed Identifier

14600397

Citation

Onusic GM, Nogueira RL, Pereira AM, Flausino Junior OA, Viana Mde B. Effects of chronic treatment with a water-alcohol extract from Erythrina mulungu on anxiety-related responses in rats. Biol Pharm Bull. 2003 Nov;26(11):1538-42. doi: 10.1248/bpb.26.1538.

Results Reference

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Anxiety Control by Erythrina Mulungu

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