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
About this trial
This is an interventional treatment trial for Pain
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
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
NCT ID
NCT05306470
First Posted
March 15, 2022
Last Updated
August 21, 2022
Sponsor
Altamash Institute of Dental Medicine
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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