Enhancing the Efficiency of EMLA Cream in Palatal Anesthesia for Children
Condition: Extrusion of Tooth
Study type: Interventional

Summary: 
      The aim of this study is to Avoid traditional palatal local injections when extracting upper
      primary teeth through enhancing the efficiency of EMLA cream by using drug delivery systems
      (permeability enhancer (DMSO), oral patches and micro-needle patches) for palatine injection.

      Group 1: Conventional local palatine injection (control group). Group 2: EMLA cream only.
      Group 3 :chemical permeability enhancer DMSO with EMLA cream. Group 4: Oral patches with EMLA
      Cream. Group 5: Micro-needle patches dissolved with EMLA Cream.
    

Detailed description: 
      The insertion of the needle and the infusion of the anesthetic solution into the palate often
      uncomfortable for the children and their acceptance of dental treatment. Therefore, there is
      a need for studies to find ways to replace the palatine injection in the modern dentistry.

      Effectiveness of Compound surfactant drugs (EMLA) have strong activity on the palatine
      tissues. Therefore, it will be chosen as an alternative to the traditional ones and will be
      enhanced by one of the drug delivery systems (physical/chemical).

      Decreased permeability of the palatine mucosa is a major reason behind using drug delivery
      systems to reach an effective therapeutic level.

      To our knowledge, this research will be the first which will be used a method of drug
      delivery systems to replace traditional palatal needle.
    

Intervention name(s): Conventional local palatine injection; EMLA cream only; chemical permeability enhancer DMSO with EMLA cream; Oral patches with EMLA Cream; Micro-needle patches dissolved with EMLA Cream
Intervention type(s): Other; Drug; Drug; Drug; Drug
Intervention description(s): Conventional palatal injection with anesthetic (lidocaine HCL2% with Epinephrine 1:80000, Korea) Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness; Emla cream will be applied at a distance of 1 mm from the palatine gingival edge by cotton buds for 3 minutes within the application area 14*14 mm and the mouth will be open throughout the procedure and the saliva will be controlled by a saliva absorbent. Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness.; Adding 10 g of EMLA cream 5%, 1,026 g of DMSO 100% and it will be applied with cotton bud for a period of 3 minutes while the child is opening his mouth and the saliva is controlled by saliva absorbent. Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness.; EMLA cream 5% will be applied at a distance of 1 mm from the palatal gingival edge using an oral patch 14*14 mm for 3 minutes and the Mouth will be closed throughout the procedure. Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness; EMLA cream 5% will be applied at a distance of 1 mm from the palatal gingival edge using an micro-needle patch 14*14 mm, 0,25 micron for 3 minutes and the Mouth will be closed throughout the procedure. Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness.
Intervention MeSH terms: Lidocaine, Prilocaine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: EMLA; Micro-needle patches; Permeability enhancer; Oral patches