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

Primary Purpose

Pain, Symptomatic Irreversible Pulpitis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Ethyl chloride
5% lidocaine gel
Sponsored by
Altamash Institute of Dental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hira Danish

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Ethyl chloride

5% lidocaine gel

control

Arm Description

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

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

Local anesthesia infiltration is administrated without using any numbing agent

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 15, 2022
Last Updated
August 21, 2022
Sponsor
Altamash Institute of Dental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05306470
Brief Title
Ethyl Chloride Versus 5% Lidocaine for Topical Anesthesia of Oral Mucosa
Official Title
Ethyl Chloride-Endo Ice Versus 5% Lidocaine for Topical Anesthesia of Oral Mucosa - a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Altamash Institute of Dental Medicine

4. Oversight

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

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Symptomatic Irreversible Pulpitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ethyl chloride
Arm Type
Experimental
Arm Description
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
Arm Title
5% lidocaine gel
Arm Type
Experimental
Arm Description
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
Arm Title
control
Arm Type
No Intervention
Arm Description
Local anesthesia infiltration is administrated without using any numbing agent
Intervention Type
Procedure
Intervention Name(s)
Ethyl chloride
Intervention Description
Application of ethyl chloride for a cooling effect to numb the area for oral infiltration anesthetic
Intervention Type
Procedure
Intervention Name(s)
5% lidocaine gel
Intervention Description
Application of 5% lidocaine gel to numb the area for oral infiltration anesthetic
Primary Outcome Measure Information:
Title
Post oral local anesthetic infiltration pain
Description
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
Time Frame
immediately after completion of administration of oral local anesthetic infiltration within 60 seconds

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hira Danish
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75500
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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