Enhancing the Efficiency of EMLA Cream in Palatal Anesthesia for Children

January 10, 2022 updated by: Damascus University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 11 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
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
EXPERIMENTAL: 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.
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.
EXPERIMENTAL: 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.
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.
EXPERIMENTAL: 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.
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
EXPERIMENTAL: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the values of each of the heart rate and oxygen rate
Time Frame: On application of the substance
The heart and oxygen rate will be recorded by pulse oximeter
On application of the substance
Evaluation conventional local palatine injection
Time Frame: On palatal probing
The heart and oxygen rate will be recorded by pulse oximeter
On palatal probing
Evaluation conventional local palatine injection
Time Frame: On extraction
The heart and oxygen rate will be recorded by pulse oximeter
On extraction
Pain levels using self-reported Wong-Baker faces pain scale
Time Frame: 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"
On application of the substance
Pain levels using self-reported Wong-Baker faces pain scale
Time Frame: On palatal probing
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"
On palatal probing
Pain levels using self-reported Wong-Baker faces pain scale
Time Frame: On extraction
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"
On extraction
Pain levels using FLACC scale
Time Frame: On application of the substance
0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 =Moderate pain, 7-10 = Severe discomfort/pain
On application of the substance
Pain levels using FLACC scale
Time Frame: On palatal probing
0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 =Moderate pain, 7-10 = Severe discomfort/pain
On palatal probing
Pain levels using FLACC scale
Time Frame: On extraction
0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 =Moderate pain, 7-10 = Severe discomfort/pain
On extraction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Farah M Babakurd, DDS, MSc student in Pedodontics, University of Damascus
  • Study Director: Shadi K Azzawi, Phd, Professor of Pedodontics, Department of Pedodontics, University of Damascus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 20, 2021

Primary Completion (ACTUAL)

August 23, 2021

Study Completion (ACTUAL)

September 27, 2021

Study Registration Dates

First Submitted

December 24, 2021

First Submitted That Met QC Criteria

January 10, 2022

First Posted (ACTUAL)

January 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Pedo-05-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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