Clinical trial NCT05912335: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dental Trauma
Local Anesthesia
Oral Cavity Disease
Keywords: Topical Anesthesia
Topical Formulation
Oral Mucosa
Lidocaine
Prilocaine
Nanostructured Lipid Carrier
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Pain sensitivity assessment by Visual Analogue Scale after the puncture of the needle of the local anesthetic.
timeFrame: 2 minutes
Secondary outcomes:
measure: Pain sensitivity assessment by Visual Analogue Scale after the injection of the local anesthetic.
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Michelle Franz Montan Braga Leite
state: São Paulo
Study officials:
References: