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

NCT ID: NCT05306470

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-04-30

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

1. :None(0)

2. : Mild (1-3)

3. : Moderate (4-6)

4. : Severe (7-10)

Conditions

Pain; Symptomatic Irreversible Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ethyl chloride

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

Group Type: EXPERIMENTAL

Ethyl chloride

Intervention Type: PROCEDURE

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

5% lidocaine gel

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

Group Type: EXPERIMENTAL

5% lidocaine gel

Intervention Type: PROCEDURE

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

control

Local anesthesia infiltration is administrated without using any numbing agent

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ethyl chloride

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

Intervention Type: PROCEDURE

5% lidocaine gel

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

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Altamash Institute of Dental Medicine

OTHER

Sponsor Role: lead

Responsible Party

Hira Abbasi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hira Danish

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

Local Anesthetic

Identifier Type: -

Identifier Source: org_study_id