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

Comparison of Effectiveness of Pre-cooling With Ethyl Chloride Versus Honey in Alleviating Intra-oral Injection Pain in Adult Patients

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

Study Overview

• Status: Completed
• Conditions: Irreversible Pulpitis
• Intervention / Treatment: Drug: Ethyl chloride; Other: Honey

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75500
      • Hira Danish

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	immediately after completion of administration of oral local anesthetic infiltration within 60 seconds

Collaborators and Investigators

• Sponsor: Altamash Institute of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: October 2, 2022
• First Submitted That Met QC Criteria: October 2, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: October 29, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ethyl Chloride
• Other Study ID Numbers: Ethyl Chloride versus Honey

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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