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

Primary Purpose

Dental Trauma, Local Anesthesia, Oral Cavity Disease

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Topical anesthetic
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dental Trauma focused on measuring Topical Anesthesia, Topical Formulation, Oral Mucosa, Lidocaine, Prilocaine, Nanostructured Lipid Carrier

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Michelle Franz Montan Braga Leite

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Experimental

Experimental

Arm Label

Topical anesthetic available on the market - Lidocaine (2.5%), Prilocaine (2.5%)

Xanthan hydrogel 2%

Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%) in NLC

Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%)

Arm Description

Applied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed. 100 mg.

Applied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed. 100 mg.

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)

Applied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed. 100 mg.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 25, 2023
Last Updated
June 12, 2023
Sponsor
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT05912335
Brief Title
Clinical Efficiency of Xanthan Hydrogels Containing Local Anesthetics Encapsulated in Nanostructured Lipid Carries
Official Title
Clinical Efficiency of Xanthan Hydrogels Containing Local Anesthetics Encapsulated in Nanostructured Lipid Carries
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
February 20, 2022 (Actual)
Study Completion Date
May 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Trauma, Local Anesthesia, Oral Cavity Disease
Keywords
Topical Anesthesia, Topical Formulation, Oral Mucosa, Lidocaine, Prilocaine, Nanostructured Lipid Carrier

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
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
ParticipantCare Provider
Masking Description
The participant and the applicator don't know which formulation was applied because these were named A, B, C, and D and the applicator doesn't have access to the data of which formulation was titled by each letter.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical anesthetic available on the market - Lidocaine (2.5%), Prilocaine (2.5%)
Arm Type
Active Comparator
Arm Description
Applied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed. 100 mg.
Arm Title
Xanthan hydrogel 2%
Arm Type
Placebo Comparator
Arm Description
Applied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed. 100 mg.
Arm Title
Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%) in NLC
Arm Type
Experimental
Arm Description
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)
Arm Title
Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%)
Arm Type
Experimental
Arm Description
Applied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed. 100 mg.
Intervention Type
Drug
Intervention Name(s)
Topical anesthetic
Other Intervention Name(s)
Topical Formulation
Intervention Description
The topical anesthetic, or topical formulation, was applied to the palatal mucosa for 2 minutes.
Primary Outcome Measure Information:
Title
Pain sensitivity assessment by Visual Analogue Scale after the puncture of the needle of the local anesthetic.
Description
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.
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Pain sensitivity assessment by Visual Analogue Scale after the injection of the local anesthetic.
Description
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.
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Michelle Franz Montan Braga Leite
City
Piracicaba
State/Province
São Paulo
ZIP/Postal Code
13414903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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