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Comparison of Effectiveness of Pre-cooling With Ethyl Chloride Versus Honey

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05568563
Recruitment Status : Completed
First Posted : October 5, 2022
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
Hira Abbasi, Altamash Institute of Dental Medicine

Brief Summary:
Comparing Pre-cooling with Ethyl Chloride versus Honey in Alleviating Intra-oral injection pain in Adult patients

Condition or disease Intervention/treatment Phase
Irreversible Pulpitis Drug: Ethyl chloride Other: Honey Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Effectiveness of Pre-cooling With Ethyl Chloride Versus Honey in Alleviating Intra-oral Injection Pain in Adult Patients
Actual Study Start Date : August 1, 2022
Actual Primary Completion Date : September 30, 2022
Actual Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine

Arm Intervention/treatment
Experimental: Ethyl chloride Drug: Ethyl chloride
Ethyl chloride is an agent that is widely used in dental practice as the standard modality for pulp vitality tests .

Experimental: Honey Other: Honey
Honey is a natural dietary product

No Intervention: Control



Primary Outcome Measures :
  1. To alleviate dental injection pain [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05568563


Locations
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Pakistan
Hira Danish
Karachi, Sindh, Pakistan, 75500
Sponsors and Collaborators
Altamash Institute of Dental Medicine
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Responsible Party: Hira Abbasi, Principal Investigator, Altamash Institute of Dental Medicine
ClinicalTrials.gov Identifier: NCT05568563    
Other Study ID Numbers: Ethyl Chloride versus Honey
First Posted: October 5, 2022    Key Record Dates
Last Update Posted: November 3, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Ethyl Chloride
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents