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Three Anxiolytic Drugs Used in Third Molar Surgery

Primary Purpose

Dental Anxiety, Impacted Third Molar Tooth

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Mulungu
Placebo
Passiflora incarnata
midazolam
Sponsored by
Universidade Federal de Sergipe
About
Eligibility
Locations
Arms
Outcomes
Full info

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 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Mulungu

placebo

Passiflora incarnata

midazolam

Arm Description

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

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

100 mg Passiflora incarnata (2 capsules of 50 mg) to be administered v.o., one hour before the surgical procedure.

15 mg midazolam (2 capsules of 7.5 mg) to be administered v.o., one hour before the surgical procedure.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 15, 2014
Last Updated
October 26, 2016
Sponsor
Universidade Federal de Sergipe
Collaborators
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT02065843
Brief Title
Three Anxiolytic Drugs Used in Third Molar Surgery
Official Title
Comparative Study of the Effectiveness of Three Anxiolytic Drugs Used in Third Molar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sergipe
Collaborators
University of Campinas, Brazil

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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%.

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 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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) to be 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) to be administered v.o., one hour before the surgical procedure.
Arm Title
Passiflora incarnata
Arm Type
Active Comparator
Arm Description
100 mg Passiflora incarnata (2 capsules of 50 mg) to be administered v.o., one hour before the surgical procedure.
Arm Title
midazolam
Arm Type
Active Comparator
Arm Description
15 mg midazolam (2 capsules of 7.5 mg) to be 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
Intervention Type
Drug
Intervention Name(s)
Passiflora incarnata
Intervention Description
100 mg/single dose/1 hour before dental surgery
Intervention Type
Drug
Intervention Name(s)
midazolam
Other Intervention Name(s)
Dormonid
Intervention Description
15 mg/single dose/1 hour before dental surgery
Primary Outcome Measure Information:
Title
Changes in anxiety report
Description
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.
Time Frame
Change from baseline to 7 days
Secondary Outcome Measure Information:
Title
Changes in blood pressure
Description
blood pressure (mmHg) will be measured before the drugs administration, 30 minutes after drugs 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) will be measured before drugs administration, 30 minutes after drugs 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) will be measured before drugs administration, 30 minutes after drugs 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

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be kept not available
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
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4192578/pdf/medoral-19-e518.pdf
Description
published article

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Three Anxiolytic Drugs Used in Third Molar Surgery

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