Clinical Efficiency of Xanthan Hydrogels Containing Local Anesthetics Encapsulated in Nanostructured Lipid Carries
Condition: Dental Trauma; Local Anesthesia; Oral Cavity Disease
MeSH terms: Mouth Diseases
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Topical anesthetic
Intervention type(s): Drug
Intervention description(s): The topical anesthetic, or topical formulation, was applied to the palatal mucosa for 2 minutes.
Other intervention name(s): Topical Formulation
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Crossover Assignment
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).
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: Topical Anesthesia; Topical Formulation; Oral Mucosa; Lidocaine; Prilocaine; Nanostructured Lipid Carrier