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

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).

Study Overview

• Status: Completed
• Conditions: Local Anesthesia; Dental Trauma; Oral Cavity Disease
• Intervention / Treatment: Drug: Topical anesthetic

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Piracicaba, São Paulo, Brazil, 13414903
      • Michelle Franz Montan Braga Leite

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Campinas, Brazil

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Actual): February 20, 2022
• Study Completion (Actual): May 3, 2022

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Prilocaine; Lidocaine; Oral Mucosa; Topical Anesthesia; Topical Formulation; Nanostructured Lipid Carrier
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: CAAE: 45317521.9.0000.5418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No