2024-515965-32-00CompletedPhase 2
Randomised, double-blind study comparing the analgesic efficacy of a lidocaine-prilocaine combination with lidocaine alone as local anesthesia for dental procedures in participants with MC1R mutation
Pharmavax AS1 site in 1 country22 target enrollmentStarted: November 27, 2024Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Successful pulpal anaesthesia measured by two consecutive 64/64 readings without any participant response, within 10 min with an electric pulp tester.
Study Overview
Brief Summary
To investigate the analgesic efficacy of a lidocaine-prilocaine combination compared to lidocaine alone in dental procedures.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants aged ≥18 and ≤
- •Written informed consent to participate in the study.
- •Participants with red hair or with at least one parent and/or grandparent with red hair and/or genetic sibling from same parents with red hair.
Exclusion Criteria
- •History or presence of hypersensitivity or allergy to lidocaine (or prilocaine or other local anesthetics (amid type or sodium metabisulfite), a history of anaphylactic or anaphylactoid reactions, or a history of other allergy that, in the opinion of the investigator, contraindicates participation.
- •Participants with known thyrotoxicosis.
- •Participants with severe heart disease, including tachycardia.
- •Local infection in the area of injection.
- •Participants with congenital or idiopathic methemoglobinemia.
Outcomes
Primary Outcomes
Successful pulpal anaesthesia measured by two consecutive 64/64 readings without any participant response, within 10 min with an electric pulp tester.
Successful pulpal anaesthesia measured by two consecutive 64/64 readings without any participant response, within 10 min with an electric pulp tester.
Secondary Outcomes
- Successful pulpal anaesthesia measured by the participants cold sensation during an ice test applied to the treated area.
- Subject’s assessment of successful soft tissue anaesthesia (yes/no) during a standard pocket procedure.
- Participant experience of anaesthesia on a scale from 1-5.
Investigators
Co-ordinating investigator
Scientific
Pharmavax AS
Study Sites (1)
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