Anxiety
Conditions
Interventions
A clinical trial was conducted, triple-blind, crossover, and randomized, approved by the Research Ethics Committee involving human subjects. All participants received information about the research th
Sponsors
Universidade Estadual Paulista Júlio de Mesquita Filho-Unesp
Universidade Estadual Paulista Júlio de Mesquita Filho-Unesp
Eligibility
Age
16 Years to 35 Years
Inclusion criteria
Inclusion criteria: Patients in good systemic and local health conditions; both sexe; patients between 16 and 35 years of age; indication of extraction of third molars (elements 18, 28, 38 or 48), with at least 2/3 of the root formed, according to radiographic evaluation, thus belonging to classification I or II and position A or B of Pell and Gregory
Exclusion criteria
Exclusion criteria: Patients who have mandibular third molars in positions 3 and C according to the Pell and Gregory classification; presence of any local manifestations in the area of interest that may contraindicate the surgical procedure, such as: pericoronitis, cysts and odontogenic tumors associated or not with the third molar, trauma in the region, or any symptomatology that indicates the presence of infection; patients who smoke or who have some type of systemic disease (of any organic system), such as diabetes, systemic arterial hypertension, hyperthyroidism, osteoporosis, gastrointestinal diseases that compromise the results of surgery or that contraindicate the administration of the drugs used in the research; patients with a history of hypersensitivity to any drug used in the research; patients who are intolerant to other materials that will be used in the research, such as 0.5% alcoholic chlorhexidine solution, 0.12% chlorhexidine digluconate solution and 2% mepivacaine hydrochloride solution with epinephrine 1:100,000; female patients who are menstruating, gestational or lactating during the period of surgical procedures; patients who have an abnormal sleep pattern, who slept less than 5 hours the night before, or use medication to control psychiatric illnesses, or who are taking medication that interferes with cortisol analyses, such as corticosteroids, estrogens and androgens
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in dental anxiety levels is expected in patients undergoing third molar protection treated with Passiflora incarnata and zolpidem, compared to the negative control (placebo) and positive control (midazolam), assessed using validated questionnaires;Statistical analysis revealed that there was no significant difference between the Passiflora incarnata, zolpidem and placebo groups in the questionnaire evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in physiological parameters related to anxiety, such as heart rate (HR), blood pressure (BP) and peripheral oxygen saturation (SpO2), are expected in the different experimental groups;In the Passiflora incarnata group, there were no statistically significant differences in heart rate (HR), systolic blood pressure (SBP) and peripheral oxygen saturation (SpO2) parameters between the groups. However, diastolic blood pressure (DBP) was statistically higher in the Passiflora incarnata group compared to the others. The zolpidem group had higher HR and SBP compared to the placebo and midazolam groups, suggesting a different physiological response that may indicate less efficacy in controlling anxiety;It is expected to measure cortisol and salivary a-amylase levels as biomarkers of stress response in relation to the evaluated protocols;In the Passiflora incarnata group, salivary cortisol expression was statistically similar between the Passiflora incarnata and midazolam groups in the pre- and postoperative periods, indicating comparable efficacy in reducing stress. In the zolpidem group in the postoperative period, salivary cortisol levels were statistically lower in the midazolam group compared to the placebo and zolpidem groups, suggesting that zolpidem may be less effective in reducing stress compared to midazolam | — |
Countries
Brazil
Contacts
Public ContactTiburtino Neto
Universidade Estadual Paulista Júlio de Mesquita Filho-Unesp
Outcome results
None listed