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Completed

NCT Number: NCT05187494

Enhancing the Efficiency of EMLA Cream in Palatal Anesthesia for Children

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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Key information

Conditions

Extrusion of Tooth

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional local palatine injection

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

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

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

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

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.

Primary outcomes

  1. 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

  2. Evaluation conventional local palatine injection

    Time frame: On palatal probing

    The heart and oxygen rate will be recorded by pulse oximeter

  3. Evaluation conventional local palatine injection

    Time frame: On extraction

    The heart and oxygen rate will be recorded by pulse oximeter

  4. 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"

  5. 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"

  6. 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"

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2022
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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