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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05912335
Other study ID # CAAE: 45317521.9.0000.5418
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 2, 2021
Est. completion date May 3, 2022

Study information

Verified date June 2023
Source University of Campinas, Brazil
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 3, 2022
Est. primary completion date February 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Brazil Michelle Franz Montan Braga Leite Piracicaba São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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