Clinical trial NCT02065843: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dental Anxiety
Impacted Third Molar Tooth
Keywords: Anxiety
Third molar surgery
Blood pressure
Heart rate
Oxygen saturation
Lead sponsor: Universidade Federal de Sergipe
Sponsor class: OTHER
Collaborators: name: University of Campinas, Brazil
First posted: 2014-02-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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

Primary outcomes:
measure: Changes in anxiety report
timeFrame: Change from baseline to 7 days
Secondary outcomes:
measure: Changes in blood pressure
timeFrame: Change from baseline to 2 hours
measure: Changes in heart rate
timeFrame: Change from baseline to 2 hours
measure: Changes in oxygen saturation
timeFrame: Change from baseline to 2 hours
Other outcomes:
Locations:
city: Aracaju
country: Brazil
facility: Federal University of Sergipe
state: Sergipe
Study officials:
affiliation: Federal University of Sergipe
name: Liane M Souza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.