Comparation between Passiflora Incarnata X Valeriana Officinalis for conscious sedation in extration of the wisdom teeth surgery

Evaluation of the actions of Passiflora Incarnata X Valeriana Officinalis for conscious sedation in anxious patients subjected to mandibular third molar extraction - a prospective, double-blind, split-mouth, and randomized study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-9xyvcyn

Enrollment

Unknown

Registered

2025-09-11

Start date

2023-07-01

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Organic anxiety disorder

Interventions

This is a prospective, double-blind, split-mouth and randomized study. The Department of Surgery and Traumatology of the State University of Maringá, Brazil, conducted all surgical procedures from Jul

D25.651

Eligibility

Age

17 Years to No maximum

Inclusion criteria

Inclusion criteria: ASA I and II physical classification from the American Society of Anesthesiologists; individuals aged 17 years or older; both sexes; asymptomatic bilateral impacted mandibular third molars in similar surgical positions; patients anxious about undergoing the procedure

Exclusion criteria

Exclusion criteria: Patients taking antidepressant and anxiolytic drugs; History of severe respiratory deficiency, obstructive sleep apnea, alcoholism, narrow-angle glaucoma, myasthenia gravis, congestive heart failure, liver and/or kidney problems, and the use of other depressant drugs; Pregnancy and/or lactation; History of local infections, such as pericoronitis; Hypersensitivity to any component of medications, substances, or materials used in the study

Design outcomes

Primary

Measure	Time frame
Hoped Outcome 1: Significant difference between the drugs at the councious level of sedation;Found Outcome 1: The consistency of physiological outcomes does not suggest differences between the phytotherapeutic drugs, apparently confirmed by the information on the self-assessment reports, in which eight patients (40%) preferred Passiflora, seven (35%) favored Valeriana, and five (25%) claimed no difference between both. However, these findings do not necessarily indicate that Valeriana inefficiently provided comfort to anxious patients during surgery. This difference more likely indicates each patient's subjectivity, as there were no significant mean differences. Sedation levels did not show statistically significant differences between Passiflora incarnata and Valeriana officinalis drugs.	—

Measure

Time frame

Hoped Outcome 1: Significant difference between the drugs at the councious level of sedation;Found Outcome 1: The consistency of physiological outcomes does not suggest differences between the phytotherapeutic drugs, apparently confirmed by the information on the self-assessment reports, in which eight patients (40%) preferred Passiflora, seven (35%) favored Valeriana, and five (25%) claimed no difference between both. However, these findings do not necessarily indicate that Valeriana inefficiently provided comfort to anxious patients during surgery. This difference more likely indicates each patient's subjectivity, as there were no significant mean differences. Sedation levels did not show statistically significant differences between Passiflora incarnata and Valeriana officinalis drugs.

—

Secondary

Measure	Time frame
Secondary outcomes are not expected	—

Countries

Brazil

Contacts

Public ContactGiovanna Fernandes

Centro de Ciências da Saúde da Universidade Estadual de Maringá

giovanna.melofernandes@hotmail.com+55-44-30114597

Outcome results

None listed

Source: REBEC (via WHO ICTRP)