Anxiety Control by Using Erythrina Mulungu in Mandibular Third Molars Extraction
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Changes in anxiety report
Study Overview
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%.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Mulungu
500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) administered v.o., one hour before the surgical procedure.
Intervention: Mulungu (Drug)
placebo
500 mg of starch (2 capsules of 250 mg) administered v.o., one hour before the surgical procedure.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Changes in anxiety report
Time Frame: 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 Outcomes
- Changes in oxygen saturation(Change from baseline to 2 hours)
- Changes in blood pressure(Change from baseline to 2 hours)
- Changes in heart rate(Change from baseline to 2 hours)
Investigators
Liane Maciel de Almeida Souza
Assistant Professor
Universidade Federal de Sergipe