Back to resultsComparison of Effectiveness of Pre-cooling With Ethyl Chloride Versus Honey
Primary Purpose
Irreversible Pulpitis
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Ethyl chloride
Honey
Sponsored by
About this trial
This is an interventional treatment trial for Irreversible Pulpitis
Eligibility Criteria
Inclusion Criteria:
- No medical history
- 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
Honey
Control
Arm Description
Outcomes
Primary Outcome Measures
To alleviate dental injection 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
NCT05568563
First Posted
October 2, 2022
Last Updated
October 29, 2022
Sponsor
Altamash Institute of Dental Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05568563
Brief Title
Comparison of Effectiveness of Pre-cooling With Ethyl Chloride Versus Honey
Official Title
Comparison of Effectiveness of Pre-cooling With Ethyl Chloride Versus Honey in Alleviating Intra-oral Injection Pain in Adult Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 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
Comparing Pre-cooling with Ethyl Chloride versus Honey in Alleviating Intra-oral injection pain in Adult patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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 Title
Honey
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Ethyl chloride
Intervention Description
Ethyl chloride is an agent that is widely used in dental practice as the standard modality for pulp vitality tests .
Intervention Type
Other
Intervention Name(s)
Honey
Intervention Description
Honey is a natural dietary product
Primary Outcome Measure Information:
Title
To alleviate dental injection 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
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No medical history
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
Comparison of Effectiveness of Pre-cooling With Ethyl Chloride Versus Honey
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