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

Sponsor

Altamash Institute of Dental Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT05306470

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

45.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Symptomatic Irreversible Pulpitis	Procedure: Ethyl chloride Procedure: 5% lidocaine gel	N/A

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Actual Primary Completion Date :

Mar 1, 2022

Actual Study Completion Date :

Apr 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Post oral local anesthetic infiltration pain [immediately after completion of administration of oral local anesthetic infiltration within 60 seconds]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hira Danish	Karachi	Sindh	Pakistan	75500

Sponsors and Collaborators

Altamash Institute of Dental Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hira Abbasi, Principal Investigator, Altamash Institute of Dental Medicine

ClinicalTrials.gov Identifier:

NCT05306470

Other Study ID Numbers:

Local Anesthetic

First Posted:

Apr 1, 2022

Last Update Posted:

Aug 24, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Pulpitis

Lidocaine

Ethyl Chloride

Study Results

No Results Posted as of Aug 24, 2022