Skip to content

Induction and regression of dental local anasthetics- Monitoring by neurophysiologically examination by Quantitative Sensory Testing (QST) considering adrenalin as vasoconstricor and Phentolamine mesilate as vasodilator

Induction and regression of dental local anasthetics- Monitoring by neurophysiologically examination by Quantitative Sensory Testing (QST) considering adrenalin as vasoconstricor and Phentolamine mesilate as vasodilator

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00016057
Enrollment
20
Registered
2019-06-26
Start date
2019-07-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

No illness or health problem is investigated, only the effects of local anesthesia on different nerve fibers are examined

Interventions

Group 1: T0: 2% Lidocaine without adrenalin (1ml) T30: Injection with sodium chloride (1ml) Group 2: T0: 2% Lidocaine with adrenalin 1:100.000 (1ml) T30: Injection with sodium chloride (1ml) Group 3:

Sponsors

Ressort Forschung und Lehre der Universitätsmedizin Mainz
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: - Age 18-40 years - Belonging ASA risk group 1, no general conditions - Body weight = 50kg - No use of permanent or acute medication - No alcohol, nicotine or coffee consumption in the last 24 hours before examination - No pain symptoms in the maxillary anterior region in the last 6 months - No dental therapy in the maxillary anterior region before the examination - No indication of neurological or psychiatric disorders - No diseases affecting the somatosensitive system - No known allergies / hypersensitivity reactions to the test substances used - Response to the local anesthetic - Non smoking - No chronic alcohol consumption - good compliance - Sufficient knowledge of German - Maxillary Canines - Clinically and anamnestically unremarkable, caries-free and filling-free, vital - Parodontium in the maxillary canine region free of inflammation - Written agreement to participate

Exclusion criteria

Exclusion criteria: - ASA Risk Group II-IV - Present contraindications for topical anesthetics, epinephrine or Phentolamine mesilate - Known allergies / hypersensitivity reactions to the test substances used, including allergy to sodium sulphite (antioxidant) - Failure to respond to the respective local anesthetic - Nicotine abuse, alcohol dependence - Persistent pain in the last 6 months - Any kind of general diseases - Regular / acute medication - History of previous problems with dental local anesthesia - Filled / carious / non-sensitive maxillary canines - Local inflammatory conditions and mucosal lesions of the oral cavity (such as gingivitis, parodontitis, leukoplakia, oral lichen planus, pemphigus vulgaris) or the skin in the test area - Reference data for the lip when collecting the first QST finding - lack of understanding of the necessary cooperation in the tests - Scar in the test area - Withdrawal of consent by the patient

Design outcomes

Primary

MeasureTime frame
Decay the local anesthetic solution and attainment of initial values t8: 220min after injection of the local anesthetic solution (will not be achieved by all subjects)

Secondary

MeasureTime frame
Termination of the standardized test series (including QST) Total decay of local anesthesia and recovery of initial values

Countries

Germany

Contacts

Public ContactJelena Zahn

Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie- Plastische Chirurgie

info.zahnstudiemainz@gmail.com067523107

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026