Clinical Efficiency of Xanthan Hydrogels Containing Local Anesthetics Encapsulated in Nanostructured Lipid Carries

Study Overview
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Brief Summary
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In a crossover, randomized, placebo-controlled, double-blind study, 40 volunteers will receive the following formulations: hydrogels containing LAs (local anesthetic) - lidocaine and prilocaine (both at 2.5%) encapsulated in CLN (XAN-CLN) or not (XAN-CLN ), EMLA (topical anesthetic available on the market) and placebo hydrogel. The formulations will be applied for 2 minutes, bilaterally on the palatal mucosa (first premolar region), in two distinct sessions. Soon after removal of the topical formulation, an AL will be performed at the region using 0.3 mL of anesthetic solution at an injection speed of 1 mL/min. Pain resulting from needle insertion and LA injection will be measured using two visual analog scales (VAS).

Detailed Description
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Dental treatment presents numerous innovations, but the pain associated with the administration of local anesthesia (LA) continuous to be a traumatic procedure for many patients. Although we use topical anesthetics (TA) to reduce pain, the commercially available formulations are only effective in preventing the pain of the needle puncture. This project aims to evaluate the clinical efficacy of xanthan-based hydrogels (2%) containing LAs encapsulated in nanostructured lipid carriers (CLN), reducing pain during puncture and injection of LA in the palatine mucosa. In a crossover, randomized, placebo-controlled, double-blind study, 40 volunteers will receive the following formulations: hydrogels containing LAs - lidocaine and prilocaine (both at 2.5%) encapsulated in CLN (XAN-CLN) or not (XAN-CLN ), EMLA and placebo hydrogel. The formulations will be applied for 2 minutes, bilaterally on the palatal mucosa (first premolar region), in two distinct sessions. Soon after the removal of the topical formulation, an AL will be performed at the region using 0.3 mL of anesthetic solution at an injection speed of 1 mL/min. The computerized Morpheus® anesthetic injector will be used in order to control the variables of volume and injection speed. Pain resulting from needle insertion and LA injection will be measured using two visual analog scales (VAS). Hydrogels containing CLN are expected to have good mechanical properties and allow the permeation of LAs efficiently through the oral mucosal epithelium. In addition, they can improve the efficacy of topical anesthesia in order to perform a painless LA in the palatal mucosa.

Official Title
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Clinical Efficiency of Xanthan Hydrogels Containing Local Anesthetics Encapsulated in Nanostructured Lipid Carries

Conditions
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Dental Trauma, Local Anesthesia, Oral Cavity Disease

Intervention / Treatment
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* Drug: Topical anesthetic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy participants No lesions in the study area Have already been submitted to local anesthesia without intercurrence Exclusion Criteria: Used any drugs that change the pain sensibility 1 week before Smokers Alcoholic

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 40 volunteers will receive the following formulations: hydrogels containing LAs - lidocaine, and prilocaine (both at 2.5%) encapsulated in CLN (XAN-CLN) or not (XAN-CLN ), EMLA and placebo hydrogel. The formulations will be applied for 2 minutes, bilaterally on the palatal mucosa (first premolar region), in two distinct sessions. Soon after the removal of the topical formulation, an AL will be performed at the region using 0.3 mL of anesthetic solution at an injection speed of 1 mL/min. Pain resulting from needle insertion and LA injection will be measured using two visual analog scales (VAS).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical anesthetic available on the market - Lidocaine (2.5%), Prilocaine (2.5%)<br>Applied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed. 100 mg. | Drug: Topical anesthetic<br>* The topical anesthetic, or topical formulation, was applied to the palatal mucosa for 2 minutes.<br>* Other names: Topical Formulation;|
| Placebo Comparator: Xanthan hydrogel 2%<br>Applied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed. 100 mg. | Drug: Topical anesthetic<br>* The topical anesthetic, or topical formulation, was applied to the palatal mucosa for 2 minutes.<br>* Other names: Topical Formulation;|
| Experimental: Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%) in NLC<br>Applied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed. 100 mg. Local Anesthetic encapsulated in nanostructured lipid carriers (NLC) | Drug: Topical anesthetic<br>* The topical anesthetic, or topical formulation, was applied to the palatal mucosa for 2 minutes.<br>* Other names: Topical Formulation;|
| Experimental: Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%)<br>Applied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed. 100 mg. | Drug: Topical anesthetic<br>* The topical anesthetic, or topical formulation, was applied to the palatal mucosa for 2 minutes.<br>* Other names: Topical Formulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain sensitivity assessment by Visual Analogue Scale after the puncture of the needle of the local anesthetic. | The blind investigator evaluated the values obtained on VAS, with a rule, the left far end mean 0, for no pain at all and the right far end mean 100 for maximum pain. Therefore, a a higher score means a worse outcome. | 2 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain sensitivity assessment by Visual Analogue Scale after the injection of the local anesthetic. | The blind investigator evaluated the values obtained on VAS, with a rule, the left far end mean 0, for no pain at all and the right far end mean 100 for maximum pain. Therefore, a a higher score means a worse outcome. | 2 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Topical Anesthesia, Topical Formulation, Oral Mucosa, Lidocaine, Prilocaine, Nanostructured Lipid Carrier