Enhancing the Efficiency of EMLA Cream in Palatal Anesthesia for Children

Extrusion of Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05187494
• Other study ID #: UDDS-Pedo-05-2021
• Status: Completed
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: September 27, 2021

Study information

• Verified date: December 2021
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 27, 2021
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Extrusion of Tooth

Intervention

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.
• 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.
• 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
• 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.

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus University	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

Barcohana N, Duperon DF, Yashar M. The relationship of application time to EMLA efficacy. J Dent Child (Chic). 2003 Jan-Apr;70(1):51-4. — View Citation

Davidovich E, Wated A, Shapira J, Ram D. The influence of location of local anesthesia and complexity/duration of restorative treatment on children's behavior during dental treatment. Pediatr Dent. 2013 Jul-Aug;35(4):333-6. — View Citation

Franz-Montan M, Ribeiro LNM, Volpato MC, Cereda CMS, Groppo FC, Tofoli GR, de Araújo DR, Santi P, Padula C, de Paula E. Recent advances and perspectives in topical oral anesthesia. Expert Opin Drug Deliv. 2017 May;14(5):673-684. doi: 10.1080/17425247.2016.1227784. Epub 2016 Sep 1. Review. — View Citation

Munshi AK, Hegde AM, Latha R. Use of EMLA: is it an injection free alternative? J Clin Pediatr Dent. 2001 Spring;25(3):215-9. — View Citation

Shaikh R, Raj Singh TR, Garland MJ, Woolfson AD, Donnelly RF. Mucoadhesive drug delivery systems. J Pharm Bioallied Sci. 2011 Jan;3(1):89-100. doi: 10.4103/0975-7406.76478. — View Citation

Outcome

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