Ethyl Chloride Versus 5% Lidocaine for Topical Anesthesia of Oral Mucosa

Ethyl Chloride-Endo Ice Versus 5% Lidocaine for Topical Anesthesia of Oral Mucosa - a Randomized Clinical Trial

Local anesthesia in the oral cavity is a pain full experience for the patient. All means should be made to reduce the pain and anxiety of the patient for needle stick procedures. My study aims in elevating the pain experienced by the patient during this procedure by using either cold application with ethyl chloride or 5% lidocaine gel.

Study Overview

• Status: Completed
• Conditions: Pain; Symptomatic Irreversible Pulpitis
• Intervention / Treatment: Procedure: Ethyl chloride; Procedure: 5% lidocaine gel

Detailed Description

Local anesthetic procedure is always a dreadful experience for the patient specially for the patients who are already in pain . It is a job of the dentist to provide a painless dental treatment from the very beginning. Most dental procedures require administration of local anesthesia for a painless procedure with local anesthesia procedure being painful itself with the administration of needle in the oral cavity. Dentist everyday in their practice utilise various techniques and procedures in alleviating this painful experience with either application of lidocaine gel or spray . Numbing the oral mucosa with cold application is well documented and tested therefore my study aims in application of ethyl chloride spray on cotton pallet for a duration of 30 seconds in producing the desired numbing effect of the oral mucosa before infiltration of local anesthesia in alleviating the needle prick sensation perceived by the patient.

Pain level is assigned to one of four categorical scores using visual analogue scale

1. :None(0)
2. : Mild (1-3)
3. : Moderate (4-6)
4. : Severe (7-10)

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75500
      • Hira Danish

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• No medical history
• No age restrictions
• Patients suffering from Symptomatic Irreversible Pulpitis requiring buccal infiltration

Exclusion Criteria:

• Patients having any medical conditions considered to affect patient safety or the quality of the study
• if they had any known hypersensitivity to local anaesthetics of amide type or any of the other contents in the substance used

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ethyl chloride; Pre cooling done by the application of single spray ethyl chloride on a cotton pellet and placed for 30 seconds at the injection site for numbing effect	Procedure: Ethyl chloride; Application of ethyl chloride for a cooling effect to numb the area for oral infiltration anesthetic
Experimental: 5% lidocaine gel; 5% lidocaine gel 2ml applied on a cotton pallet for 30 seconds on the oral mucosa at the site of injection for the numbing effect	Procedure: 5% lidocaine gel; Application of 5% lidocaine gel to numb the area for oral infiltration anesthetic
No Intervention: control; Local anesthesia infiltration is administrated without using any numbing agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post oral local anesthetic infiltration pain	Post administration of oral local anesthetic infiltration pain will be measured by using Visual Analogue Scale(VAS) which is an 10-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured	immediately after completion of administration of oral local anesthetic infiltration within 60 seconds

Collaborators and Investigators

• Sponsor: Altamash Institute of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 21, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Ethyl Chloride
• Other Study ID Numbers: Local Anesthetic

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
• product manufactured in and exported from the U.S.: No