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This study is Phase 4 trial which evaluates the safety and efficacy of 2% Lidocaine HCl with different epinephrine concentration in patients undergoing surgical extraction of impacted lower third molars
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2% Lidocaine HCL:Epinephrine inj. | Experimental | 2% Lidocaine HCL with epinephrine 1:200,000 |
|
| 2% Lidocaine HCL:Epinephrine inj. (3M) | Active Comparator | 2% Lidocaine HCl with epinephrine 1:80,000 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% lidocaine HCl with epinephrine 1:200,000 | Drug |
| ||
| 2% lidocaine HCl with epinephrine 1:80,000 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain visual analogue scale (VAS) | To acess the pain immediately after the surgical extraction of impacted lower third molars | Immediately after the extraction |
| Measure | Description | Time Frame |
|---|---|---|
| Onset time of anesthesia | Immediately after administration of IP | |
| Local anesthetic duration | Immediately after onset of anesthesia | |
| Pain VAS |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huons | Ansan | Kyeonggi-do | 426791 | South Korea |
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| Drug |
|
| 2, 4, 6 hours after administration of the investigational product (IP) |
| Onset time of pain after administration of IP | Immediately after injection |
| Bleeding after extraction measured by the operator | Immediately after extraction |
| Questionnaire of satisfaction level of the operator | Immediately after extraction |
| Questionnaire of satisfaction level of the subjects | Immediately after extraction |
| Dosage of administrated IP | immediately after injection |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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