Three Anxiolytic Drugs Used in Third Molar Surgery

Dental Anxiety Clinical Trial

Official title:

Comparative Study of the Effectiveness of Three Anxiolytic Drugs Used in Third Molar Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065843
• Other study ID #: ANSI-388.427
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 15, 2014
• Last updated: October 26, 2016
• Start date: March 2014
• Est. completion date: September 2014

Study information

• Verified date: October 2016
• Source: Universidade Federal de Sergipe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Anxiety
• Impacted Third Molar Tooth
• Tooth, Impacted

Intervention

Drug:
• Mulungu
500 mg/single dose/1 hour before dental surgery
• Placebo
500 mg/single dose/1 hour before dental surgery
• Passiflora incarnata
100 mg/single dose/1 hour before dental surgery
• midazolam
15 mg/single dose/1 hour before dental surgery

Locations

Country	Name	City	State
Brazil	Federal University of Sergipe	Aracaju	Sergipe

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Sergipe	University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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.	Change from baseline to 2 hours	No
Secondary	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	No

External Links

•   published article