Extrusion of Tooth
Conditions
Keywords
EMLA, Micro-needle patches, Permeability enhancer, Oral patches
Brief 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.
Interventions
OTHERConventional local palatine injection
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
DRUGEMLA cream only
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.
DRUGchemical permeability enhancer DMSO with EMLA cream
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.
DRUGOral patches with EMLA Cream
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
DRUGMicro-needle patches dissolved with EMLA Cream
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.
Sponsors
Damascus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* no previous dental experience. * Healthy children. * Definitely positive or positive ratings of Frank scale * Child did not receive any sedative or pain drugs during the last three. * Presence of upper primary teeth, an indication for extraction
Exclusion criteria
* Presence of general diseases or health problems. * Uncooperative children * Children with congenital or idiopathic Methemoglobin * Teeth with severe abscesses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the values of each of the heart rate and oxygen rate | On application of the substance | The heart and oxygen rate will be recorded by pulse oximeter |
| Evaluation conventional local palatine injection | On palatal probing | The heart and oxygen rate will be recorded by pulse oximeter |
| Pain levels using self-reported Wong-Baker faces pain scale | On application of the substance | 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 |
| Pain levels using FLACC scale | On application of the substance | 0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 =Moderate pain, 7-10 = Severe discomfort/pain |
Countries
Syria
Outcome results
None listed