Clinical trial NCT05187494: Enhancing the Efficiency of EMLA Cream in Palatal Anesthesia for Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extrusion of Tooth
Keywords: EMLA
Micro-needle patches
Permeability enhancer
Oral patches
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 75
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the values of each of the heart rate and oxygen rate
timeFrame: On application of the substance
measure: Evaluation conventional local palatine injection
timeFrame: On palatal probing
measure: Evaluation conventional local palatine injection
timeFrame: On extraction
measure: Pain levels using self-reported Wong-Baker faces pain scale
timeFrame: On application of the substance
measure: Pain levels using self-reported Wong-Baker faces pain scale
timeFrame: On palatal probing
measure: Pain levels using self-reported Wong-Baker faces pain scale
timeFrame: On extraction
measure: Pain levels using FLACC scale
timeFrame: On application of the substance
measure: Pain levels using FLACC scale
timeFrame: On palatal probing
measure: Pain levels using FLACC scale
timeFrame: On extraction
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus University
Study officials:
affiliation: MSc student in Pedodontics, University of Damascus
name: Farah M Babakurd, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Pedodontics, Department of Pedodontics, University of Damascus
name: Shadi K Azzawi, Phd
role: STUDY_DIRECTOR
References:
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. doi: 10.17796/jcpd.25.3.hn62713500418728.
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.
citation: 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.
citation: Franz-Montan M, Ribeiro LNM, Volpato MC, Cereda CMS, Groppo FC, Tofoli GR, de Araujo 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.
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.