NCT05187494

Enhancing the Efficiency of EMLA Cream in Palatal Anesthesia for Children

A Study of the Role of Some Drug Delivery Systems in Enhancing the Efficiency of EMLA Cream in Palatal Anesthesia for Children Aged Between 7-11 Years Old

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Damascus University · Academic / Other
• Sex: All
• Age: 7 Years – 11 Years
• Healthy volunteers: Accepted

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.

Conditions

• Extrusion of Tooth

Interventions

Type	Name	Description
OTHER	Conventional 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
DRUG	EMLA 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.
DRUG	chemical 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.
DRUG	Oral 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
DRUG	Micro-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.

Timeline

• Start date: 2021-05-20
• Primary completion: 2021-08-23
• Completion: 2021-09-27
• First posted: 2022-01-11
• Last updated: 2022-01-11

Locations

1 site across 1 country: Syria