Local Anesthesia Clinical Trial
Official title:
Efficacy and Safety of Pulpal Anesthesia After Anterior and Middle Superior Alveolar (AMSA) Nerve Block Obtained by Articaine Computer-controlled and Conventional Delivery
Verified date | July 2015 |
Source | University of Belgrade |
Contact | n/a |
Is FDA regulated | No |
Health authority | Serbia: Ethics Committee |
Study type | Interventional |
The purpose of this study was to investigate and compare pulpal anesthesia and cardiovascular parameters obtained with 0.6 ml of 4% articaine with epinephrine (1:100.000) for anterior and middle superior alveolar nerve (AMSA) block performed by standard and computer-controlled delivery in healthy volunteers.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - ASA I - full maxillary dental arch - vital maxillary teeth without caries, restorations, periodontal disease or history of trauma Exclusion Criteria: - allergies to local anesthetic solution ingredients, food and drugs - alcohol and drugs abuse - heavy tobacco smoking |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Serbia | School of Dental Medicine, University of Belgrade | Belgrade |
Lead Sponsor | Collaborator |
---|---|
University of Belgrade |
Serbia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of pulpal anesthesia | Duration of pulpal maxillary anesthesia of all maxillary teeth in anesthetized side of upper jaw assessed by electrical pulp testing at 2-minute intervals. | up to 64 minutes from baseline | No |
Secondary | Onset of pulpal anesthesia | Pulpal response to electrical pulp tester measured up to 8 minutes after injection | Up to 8 minutes | No |
Secondary | Width of anesthetic field marginal-superior | Width of area of soft tissue numbness measured 5 minutes after injection | 5 minutes | No |
Secondary | Width of anesthetic field medial-lateral | Width of area of soft tissue numbness measured 5 minutes after injection | 5 minutes | No |
Secondary | Duration of soft tissue anesthesia buccal | Duration of soft tissue numbness followed up to 120 minutes after injection | Up to 120 min | No |
Secondary | Duration of soft tissue anesthesia palatal | Duration of soft tissue numbness followed up to 120 minutes after injection | Up to 120 minutes | No |
Secondary | Systolic blood pressure at baseline | Systolic blood pressure before injection | 0 minutes | Yes |
Secondary | Systolic blood pressure at 5 minutes | Changes in systolic blood pressure from baseline at the time of injection delivery | 0, 5 minutes | Yes |
Secondary | Systolic blood pressure at 10 minutes | Changes in systolic blood pressure from baseline 5 minutes after injection delivery | 0, 10 minutes | Yes |
Secondary | Systolic blood pressure at 15 minutes | Changes in systolic blood pressure from baseline 10 minutes after injection delivery | 0, 15 minutes | Yes |
Secondary | Systolic blood pressure at 20 minutes | Changes in systolic blood pressure from baseline 15 minutes after injection delivery | 0, 20 minutes | Yes |
Secondary | Systolic blood pressure at 35 minutes | Changes in systolic blood pressure from baseline 30 minutes after injection delivery | 0, 35 minutes | Yes |
Secondary | Diastolic blood pressure at baseline | Diastolic blood pressure before injection | 0 minutes | Yes |
Secondary | Diastolic blood pressure at 5 minutes | Changes in diastolic blood pressure from baseline at the time of injection delivery | 0, 5 minutes | Yes |
Secondary | Diastolic blood pressure at 10 minutes | Changes in diastolic blood pressure from baseline 5 minutes after injection delivery | 0, 10 minutes | Yes |
Secondary | Diastolic blood pressure at 15 minutes | Changes in diastolic blood pressure from baseline 10 minutes after injection delivery | 0, 15 minutes | Yes |
Secondary | Diastolic blood pressure at 20 minutes | Changes in diastolic blood pressure from baseline 15 minutes after injection delivery | 0, 20 minutes | Yes |
Secondary | Diastolic blood pressure at 35 minutes | Changes in diastolic blood pressure from baseline 30 minutes after injection delivery | 0, 35 minutes | Yes |
Secondary | Heart rate at baseline | Heart rate before injection delivery | 0 minutes | Yes |
Secondary | Heart rate at 5 minutes | Changes in heart rate from baseline at the time of injection delivery | 0, 5 mninutes | Yes |
Secondary | Heart rate at 10 minutes | Changes in heart rate from baseline 5 minutes after injection delivery | 0, 10 minutes | Yes |
Secondary | Heart rate at 15 minutes | Changes in heart rate from baseline 10 minutes after injection delivery | 0, 15 minutes | Yes |
Secondary | Heart rate at 20 minutes | Changes in heart rate from baseline 15 minutes after injection delivery | 0, 20 minutes | Yes |
Secondary | Heart rate at 35 minutes | Changes in heart rate from baseline 30 minutes after injection delivery | 0, 35 minutes | Yes |
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