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Completed

NCT Number: NCT05306470

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hira Danish

Karachi, Sindh, 75500, Pakistan

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ethyl chloride

Procedure

Application of ethyl chloride for a cooling effect to numb the area for oral infiltration anesthetic

5% lidocaine gel

Procedure

Application of 5% lidocaine gel to numb the area for oral infiltration anesthetic

Primary outcomes

  1. Post oral local anesthetic infiltration 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

Sponsors and collaborators

Lead sponsor

Altamash Institute of Dental Medicine

Other

Registry information

Official study title

Ethyl Chloride-Endo Ice Versus 5% Lidocaine for Topical Anesthesia of Oral Mucosa - a Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2022
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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