Dental Anxiety, Impacted Third Molar Tooth
Conditions
Keywords
Anxiety, Third molar surgery, Blood pressure, Heart rate, Oxygen saturation
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%.
Interventions
DRUGMulungu
500 mg/single dose/1 hour before dental surgery
DRUGPlacebo
500 mg/single dose/1 hour before dental surgery
Sponsors
University of Campinas, Brazil
Liane Maciel de Almeida Souza
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood pressure | Change from baseline to 2 hours | 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 | Change from baseline to 2 hours | 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 | Change from baseline to 2 hours | oxygen saturation (SpO2) was measured before drug administration, 30 minutes after drug administration and during local anesthesia, incision, tooth removal and suturing. |
Countries
Brazil
Outcome results
None listed