Dental Anxiety
Conditions
Interventions
This was a randomized, controlled, double-blind, split-mouth clinical trial that assessed the level of anxiety through the patients perception of the preemptive use of Passiflora incarnata (260 mg) co
HP4.018.602.600.676
D27.505.954.427.700.872.015
Sponsors
Faculdade de Odontologia da Universidade Federal do Rio Grande do Sul
Pró Reitoria de Pesquisa da Universidade Federal do Rio Grande do Sul
Eligibility
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Be between 18 and 40 years old; both genders; have two asymptomatic homologous third molars (upper or lower); same classification as Pell and Gregory and Winter for homologous teeth; same angulation of the third molars in relation to the second molars
Exclusion criteria
Exclusion criteria: Pregnant; lactating; American Society of Anesthesiologists (ASA) classification as patient III or IV; history of use of medication for pain or anxiety in the 15 days prior to the study; history of hypersensitivity to substances or materials used in the experiment; patients unable to undergo surgical procedures with local anesthesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: It is expected to observe a reduction of at least 1 point in self-reported anxiety scores on the modified Visual Analog Scale (VAS) associated with preoperative use of Passiflora incarnata (260 mg), when compared to placebo. Assessments was performed at four time points: seven days before the procedure, immediately before surgery, immediately after surgery, and 24 hours post-procedure, using the Corah Dental Anxiety Scale and the modified VAS.;Observed outcome 1: No statistically significant difference was found between groups regarding self-reported anxiety, as measured by the modified Visual Analog Scale and the Corah Dental Anxiety Scale, at any of the four time points evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: It is expected that the preoperative use of Passiflora incarnata (260 mg) will not produce clinically relevant changes in systolic or diastolic blood pressure or heart rate values, when compared to the placebo group. Hemodynamic stability will be assessed through measurements taken at three distinct time points (seven days before, immediate preoperative, and immediate postoperative periods), using standardized equipment and a single examiner.;Observed outcome 2: No statistically significant differences were observed in systolic or diastolic blood pressure or heart rate values between the Passiflora incarnata and placebo groups at any of the three evaluated time points. ;Expected outcome 3: It is expected that patients undergoing third molar extraction with preoperative use of Passiflora incarnata (260 mg) will report an improved subjective experience, as assessed 24 hours after the procedure. Outcome measured using a standardized self-assessment questionnaire.;Observed outcome 3: The self-assessment performed 24 hours after the procedure indicated no statistically significant difference between groups regarding sensations reported during surgery. However, the data suggested a favorable trend in the Passiflora incarnata group, with a higher proportion of patients reporting feeling calm (26% vs. 16%) and a lower proportion reporting feeling very anxious (7% vs. 17%) compared to the placebo group.;Expected outcome 4: It is expected that the use of Passiflora incarnata (260 mg) will not be associated with a significant increase in the occurrence of adverse effects, such as nausea, vomiting, allergic reactions, or sensory disturbances, when compared to placebo. Outcome assessed using a standardized post-procedure questionnaire, with a relative frequency difference of less than 5% between groups considered acceptable.;Observed outcome 4: Most of the reported adverse effects, such as nausea, vomiting, and allergic reactions, did not show statistically s | — |
Countries
Brazil
Contacts
Public ContactMaurício Mollar
Faculdade de Odontologia da Universidade Federal do Rio Grande do Sul
Outcome results
None listed