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
Sponsored by
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
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
No
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
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
background
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
background
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Anxiety Control by Erythrina Mulungu
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