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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated ropivacaine formulations.
This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated 1 and 2% ropivacaine gel formulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal ropivacaine, topical | Placebo Comparator | The topical anesthetics were applied at the region of right and left maxillary lateral incisors at the buccal mucosa. |
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| Liposomal ropivacaine, palatal mucosa | Placebo Comparator | Topical formulations were applied at the palatal mucosa at the right canine region and efficacy of topical formulations was accessed through insertion of a 30 gauge needle and injection of anesthetic solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | 100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| After topical application of the local anesthetic formulations at the oral mucosa, their influence on pulpal response was assessed by an electrical pulp tester. | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of the topical anesthetics was measured after a simulation of a local anesthesia in the application site (insertion of a 30 gauge needle until periosteum contact). | 10 seconds after removal of topical formulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Piracicaba Dental School | Piracicaba | São Paulo | 13414903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21112538 | Derived | Franz-Montan M, de Paula E, Groppo FC, Silva AL, Ranali J, Volpato MC. Liposome-encapsulated ropivacaine for intraoral topical anesthesia. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Dec;110(6):800-4. doi: 10.1016/j.tripleo.2010.07.005. | |
| 21106282 | Derived | Franz-Montan M, de Paula E, Groppo FC, Silva AL, Ranali J, Volpato MC. Liposomal delivery system for topical anaesthesia of the palatal mucosa. Br J Oral Maxillofac Surg. 2012 Jan;50(1):60-4. doi: 10.1016/j.bjoms.2010.10.018. Epub 2010 Nov 23. |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D000758 | Anesthesia |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine | Drug | 100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 20% benzocaine gel were applied once during 30 minutes. |
|
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| D000588 |
| Amines |
| D000760 | Anesthesia and Analgesia |