Three Anxiolytic Drugs Used in Third Molar Surgery

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02065843

Enrollment

Registered

2014-02-19

Start date

2014-03-31

Completion date

2014-09-30

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Anxiety, Impacted Third Molar Tooth

Keywords

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

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%.

Interventions

DRUGMulungu

500 mg/single dose/1 hour before dental surgery

DRUGPlacebo

500 mg/single dose/1 hour before dental surgery

DRUGPassiflora incarnata

100 mg/single dose/1 hour before dental surgery

DRUGmidazolam

15 mg/single dose/1 hour before dental surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in anxiety report	Change from baseline to 7 days	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

Measure	Time frame	Description
Changes in blood pressure	Change from baseline to 2 hours	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	Change from baseline to 2 hours	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	Change from baseline to 2 hours	oxygen saturation (SpO2) will be measured before drugs administration, 30 minutes after drugs administration and during local anesthesia, incision, tooth removal and suturing.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026