Enhancing the Efficiency of EMLA Cream in Palatal Anesthesia for Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-20

Study Completion Date

2021-09-27

Brief Summary

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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.

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Detailed Description

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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

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Extrusion of Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional local palatine injection

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.

Group Type OTHER

Conventional local palatine injection

Intervention Type OTHER

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 only

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.

Group Type EXPERIMENTAL

EMLA cream only

Intervention Type DRUG

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.

chemical permeability enhancer DMSO with EMLA cream

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.

Group Type EXPERIMENTAL

chemical permeability enhancer DMSO with EMLA cream

Intervention Type DRUG

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.

Oral patches 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.

Group Type EXPERIMENTAL

Oral patches with EMLA Cream

Intervention Type DRUG

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

Micro-needle patches dissolved 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.

Group Type EXPERIMENTAL

Micro-needle patches dissolved with EMLA Cream

Intervention Type DRUG

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.

Interventions

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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

Intervention Type OTHER

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.

Intervention Type 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.

Intervention Type 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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes