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Cannabis-derived product for analgesia in third molar surgery: A randomized, double-blind clinical trial

Cannabidiol for preemptive analgesia in third molar extraction: A randomized, double-blind clinical trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-5hd8ckd
Enrollment
Unknown
Registered
2025-09-25
Start date
2025-08-13
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

Cannabidiol

Interventions

This is a randomized, double-blind, crossover, within-person study. Data from previous studies with similar outcome assessment methodology to this study were used to calculate the sample size. The sam
V03.175.250.500.500

Sponsors

Faculdade de Odontologia da Universidade de São Paulo - FOUSP
Lead Sponsor
Faculdade de Odontologia da Universidade de São Paulo - FOUSP
Collaborator

Eligibility

Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Healthy participants without systemic involvement; of both genders; aged between 18 and 40 years; who required extraction of bilaterally impacted lower third molars diagnosed by orthopantomograms; Teeth with similar bilateral bone impactions, assessed by panoramic radiography, presenting the same dental impaction classification (IIB) according to Pell and Gregory (1933) and Winter (1926)

Exclusion criteria

Exclusion criteria: Research participants who used analgesics or anti-inflammatories in the 48 hours prior to tooth extractions; research participants with sensory-sensory alterations; research participants who are pregnant or lactating, or who present a positive rapid pregnancy test (to be performed on the day of the procedure); research participants with any history of hypersensitivity reactions to any of the medications that will be used in the study: mepivacaine, amoxicillin, ibuprofen, dipyrone, chlorhexidine, and cannabidiol; research participants who test positive at the time of surgery for previous use of Cannabis sativa (Test to be performed on the day of the procedure); research participants who present an infection or postoperative alveolith; research participants who do not follow postoperative recommendations; research participants who do not attend follow-up appointments; when the surgical time exceeds 60 minutes; when technical failure in anesthesia occurs or when the use of more than 3 anesthetic tubes is necessary; research participants who use any medication with analgesic and/or anti-inflammatory action in the postoperative period, in addition to those prescribed in the study protocol

Design outcomes

Primary

MeasureTime frame
Expected outcome: To evaluate the use of Cannabidiol as a strategy for preemptive analgesia

Secondary

MeasureTime frame
Expected outcome: It is expected a reduction of preoperative anxiety

Countries

Brazil

Contacts

Public ContactBergson de Moraes

Faculdade de Odontologia da Universidade de São Paulo - FOUSP

bergsoncarvalho@usp.br+55-011-30917418

Outcome results

None listed

Source: REBEC (via WHO ICTRP)