Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2016
INTERVENTION: D02.241.223.100.050.500.687 HP3.073.433.101 Procedure/surgery We selected 10 individuals to participate in the study, all covered 2 times during development work, with the interval of 7 days in each procedure performed, which consisted of 10 patients participating in both groups (test group + placebo group). 10 participants in the test group they had to completely dry oral mucosa with the aid of a sterile dry gauze, after removing the gauze for two minutes underwent application of topical anesthetic benzocaine 20% Benzotop® site (DFL, São Paulo, Brazil ), a procedure that took place in two stages (in the region in the infraorbital nerve and region of the posterior superior alveolar nerve) prior to gauge needle puncture 30 of Injex® mark (Ourinhos, São Paulo, Brazil) mounted on a carpule syringe for infiltration 1 cartridge of 2% lidocaine with epinephrine at a concentration of 1: 100.00 (1,8ml) (DFL, São Paulo, Brazil) on one side of the oral cavity. After an interval of seven days, in a second period of the experiment, the same 10 patients were included in the control group being experienced the opposite site to the next test (test group). The oral cavity on the opposite side was also completely dry and with the aid of sterile gauze and after removal of same for two minutes topical application of placebo underwent (without topical anesthetic action) procedure also occurred in two moments (in the region in the infraorbital nerve and region of the posterior superior alveolar nerve) prior to puncture needle gauge of 30 Injex® mark (Ourinhos, São Paulo, Brazil) mounted on a carpule syringe for infiltration 1 cartridge of lidocaine 2% epinephrine at a concentration of 1: 100.00 (1,8ml) (DFL, São Paulo, Brazil) on the opposite side of the oral cavity. The products covered had their packaging and the codes were broken only after statistical analysis. As there is pain of difference from the anterior and posterior maxilla by the presence of more nerve endings in the anterior region, the anesthetics were performed CONDITION: The study is to assess the reduction of, PAIN , during anesthesia , conducted in human volunteers, previously screened healthy requiring dental treatment with anesthetic approach to sensory block the, PAIN. ; C10.597.617 C10.597.617 SECONDARY OUTCOME: Pain assessment in patients undergoing local anesthesia using topical anesthetic compared to placebo in local anesthesia in two regions of the oral cavity. ; Puncture needles to lock infraorbitary and posterior superior alveolar nerve. The anterior maxillary region, innervated by infraorbitary has the largest presence of nerve endings, the prior application of 20% benzocaine topical anesthetic results in less pain in puncture needles for blocking the infraorbital nerve as compared to placebo, statistically confirmed (p = 0.04) using the Student's t test. INCLUSION CRITERIA: Patients over 18 years of age, healthy, with dental history allergic sensitivity to anesthetic free or their components. The maximum blood pressure to consider normotensive patients was 139/89 mmHg. PRIMARY OUTCOME: To evaluate the efficacy of topical anesthetic (benzocaine 20%) compared to placebo in reducing pain, heart rate and blood pressure at the needle puncture sites in anesthesia.; Heart rate and blood pressure were assessed 10 minutes before needle puncture during the procedure, and 10 minutes after anesthetic infiltration using Omron® HEM 742 Automatic machine. The perception of pain was evaluated during needle puncture through the Visual Analogue Scale (VAS) in all experimental procedures. When assessing the efficacy of topical anesthetic (benzocaine 20%) compared to placebo, we found that reduction of pain, quantified by the patients by a Visual Analog Scale, the needles to puncture the infraorbital region obtaining satisfactory results statistically (p = 0.04) with the use of topical anesthetic benzocaine 20%. Heart rate and blood pressure measured 10 minutes before the puncture needle at the time of the procedure, and 10 minutes after anesthetic infiltration using Omron® HEM 742 Automatic device. It resulted in no statistically significant difference.; Data normality was tested by the Shapiro‐Wilk test. Descriptive measurements were evaluated using mean and standard deviation. Differences between groups were evaluated using Student's t test. The level of significance was set at 5%
Epistemonikos ID: 393a22184c823a8332b391da9d490ed3a36da651
First added on: Aug 24, 2024