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Comparison of the anxiolytic effect during dental anesthesia

Comparison of the anxiolytic effect of Valerian officinalis l., Diazepam and Nitrous oxide during Dental anesthesia

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-10v56ctt
Enrollment
Unknown
Registered
2025-03-20
Start date
2024-08-12
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

Dental Anxiety, Local Anesthesia, Conscious Sedation

Interventions

This is a randomized, controlled, four-arm, double-blind clinical trial with 70 participants (35 men and 35 women) aged between 18 and 40 years. Participants will be randomly allocated to one of four
B01.875.800.575.912.250.328.937.888
D01.650.550.587.650
HP3.073.433.101

Sponsors

Universidade Estadual de Campinas
Collaborator
Universidade Estadual de Campinas
Lead Sponsor

Eligibility

Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Volunteers whose ages are between 18 and 40 years old; participants classified as ASA I; who have the upper 2nd molar used as a reference for application of the anesthetic technique

Exclusion criteria

Exclusion criteria: Patients under 18 or over 40 years of age will be excluded from the study; those weighing less than 50 kg or more than 90 kg; those who have never undergone anesthesia; those with a history of contraindications to the use of benzodiazepines or Valerian; and those with claustrophobia or mouth breathing

Design outcomes

Primary

MeasureTime frame
Reduction of anxiety at the time of anesthesia, assessed by the Modified Dental Anxiety Scale MDAS and complemented by vital signs, such as heart rate, blood pressure and oxygen saturation, salivary cortisol and anterograde amnesia

Secondary

MeasureTime frame
Impact on vital signs such as heart rate, blood pressure and oxygen saturation, salivary cortisol levels, anterograde amnesia, Trieger test performance and pain scale

Countries

Brazil

Contacts

Public ContactCamila Candido

Universidade Estadual de Campinas

camilaca@unicamp.br+55(11)971312599

Outcome results

None listed

Source: REBEC (via WHO ICTRP)