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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
75
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.
Damascus University
Damascus, Syria
Changes in the values of each of the heart rate and oxygen rate
The heart and oxygen rate will be recorded by pulse oximeter
Time frame: On application of the substance
Evaluation conventional local palatine injection
The heart and oxygen rate will be recorded by pulse oximeter
Time frame: On palatal probing
Evaluation conventional local palatine injection
The heart and oxygen rate will be recorded by pulse oximeter
Time frame: On extraction
Pain levels using self-reported Wong-Baker faces pain scale
0= "no hurt", 2= "hurts a little bit", 4="hurts a little more", 6= "hurts even more", 8= "hurts a whole lot", 10= "hurts worst"
Time frame: On application of the substance
Pain levels using self-reported Wong-Baker faces pain scale
0= "no hurt", 2= "hurts a little bit", 4="hurts a little more", 6= "hurts even more", 8= "hurts a whole lot", 10= "hurts worst"
Time frame: On palatal probing
Pain levels using self-reported Wong-Baker faces pain scale
0= "no hurt", 2= "hurts a little bit", 4="hurts a little more", 6= "hurts even more", 8= "hurts a whole lot", 10= "hurts worst"
Time frame: On extraction
Pain levels using FLACC scale
0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 =Moderate pain, 7-10 = Severe discomfort/pain
Time frame: On application of the substance
Pain levels using FLACC scale
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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.
0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 =Moderate pain, 7-10 = Severe discomfort/pain
Time frame: On palatal probing
Pain levels using FLACC scale
0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 =Moderate pain, 7-10 = Severe discomfort/pain
Time frame: On extraction