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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

Not Applicable
Conditions
o illness or health problem is investigated, only the effects of local anesthesia on different nerve fibers are examined
Registration Number
DRKS00016057
Lead Sponsor
Ressort Forschung und Lehre der Universitätsmedizin Mainz
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Male
Target Recruitment
20
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

- 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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Decay the local anesthetic solution and attainment of initial values<br>t8: 220min after injection of the local anesthetic solution (will not be achieved by all subjects)
Secondary Outcome Measures
NameTimeMethod
Termination of the standardized test series (including QST)<br>Total decay of local anesthesia and recovery of initial values
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