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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515965-32-00
Acronym
PVX 2024-01
Enrollment
22
Registered
2024-11-27
Start date
2024-12-09
Completion date
2024-12-31
Last updated
2024-11-27

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

Conditions

Subjects having local anesthesia for dental procedures.

Brief summary

Successful pulpal anaesthesia measured by two consecutive 64/64 readings without any participant response, within 10 min with an electric pulp tester.

Detailed description

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.

Interventions

DRUGCitanest® Dental Octapressin 30 mg/ml + 0
DRUG03 IE/ml
DRUGXylocain ®Dental adrenalin 20 mg/ml + 12
DRUG5 mikrog/ml Injeksjonsvæske
DRUGoppløsning i sylindretter

Sponsors

Pharmavax AS
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Successful pulpal anaesthesia measured by two consecutive 64/64 readings without any participant response, within 10 min with an electric pulp tester.

Secondary

MeasureTime frame
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.

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026