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

NCT05912335 | Completed Phase 1 DMC

• 1 other identifier: CAAE: 45317521.9.0000.5418
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Trauma; Local Anesthesia; Oral Cavity Disease

Keywords

Topical Anesthesia; Topical Formulation; Oral Mucosa; Lidocaine; Prilocaine; Nanostructured Lipid Carrier

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain sensitivity assessment by Visual Analogue Scale after the injection of the local anesthetic.

  2 minutes

Study Arms (4)

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

ACTIVE COMPARATOR

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

Drug: Topical anesthetic

Xanthan hydrogel 2%

PLACEBO COMPARATOR

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

Drug: Topical anesthetic

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Drug: Topical anesthetic

Interventions

Topical anesthetic DRUG

The topical anesthetic, or topical formulation, was applied to the palatal mucosa for 2 minutes.

Also known as: Topical Formulation

Topical anesthetic available on the market - Lidocaine (2.5%), Prilocaine (2.5%); Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%); Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%) in NLC; Xanthan hydrogel 2%

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants
• No lesions in the study area
• Have already been submitted to local anesthesia without intercurrence

You may not qualify if:

• Used any drugs that change the pain sensibility 1 week before
• Smokers
• Alcoholic

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Michelle Franz Montan Braga Leite

Piracicaba, São Paulo, 13414903, Brazil

Location

MeSH Terms

Conditions

Mouth Diseases

Interventions

Anesthetics, Local; Dosage Forms

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 22, 2023
• Study Start: June 2, 2021
• Primary Completion: February 20, 2022
• Study Completion: May 3, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)