An interventional study of Conventional local palatine injection and EMLA cream only in Extrusion of Tooth, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 7 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
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.
Damascus University is the lead sponsor of 206 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Conventional palatal injection with anesthetic (lidocaine 2% with Epinephrine 1:80000, Korea) will be performed and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child.
Other: Conventional local palatine injection
The palatine mucosa will be dried with a cotton ball 2\*2 and then 0,2 g of Emla cream will be applied for 3 minutes . During this period and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child.
Drug: EMLA cream only
The palatine mucosa will be dried with a cotton ball and then EMLA cream will be mixed with a permeability enhancer in the laboratory of pharmaceutical industries at the Faculty of Pharmacy at Damascus University according to the following: 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. During this period and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child.
Drug: chemical permeability enhancer DMSO with EMLA cream
The palatine mucosa will be dried with a cotton ball and then 0.2 g of EMLA cream 5% will be applied by using an oral patch 14\*14 mm for 3 minutes. During this period and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child.
Drug: Oral patches with EMLA Cream
The palatine mucosa will be dried with a cotton ball 2\*2 and then 0.2 g of EMLA cream 5% will be applied by using an micro-needle patch 14\*14 mm, 0,25 micron for 3 minutes.
Drug: Micro-needle patches dissolved with EMLA Cream
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.
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
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
Plan to share: No
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Damascus University