Comparing Pain Levels With or Without Topical Anesthesia During Infiltration Injection in Patients Undergoing Tooth Extraction.

NCT07707557 | Active Not Recruiting Early Phase 1 DMC

• 1 other identifier: IRB/KMDC/KMU/26/2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial aims to assess whether the application of 5% topical lidocaine before infiltration anesthesia reduces pain in patients undergoing tooth extraction. A total of 120 participants will be randomly assigned to receive either infiltration anesthesia alone or infiltration anesthesia preceded by topical lidocaine. Pain will be evaluated using the Visual Analogue Scale (VAS) at predetermined intervals following the procedure. The study seeks to determine the effectiveness of topical anesthesia as a simple adjunctive measure for improving patient comfort and reducing injection-related pain during routine dental extractions. Findings from this research may help optimize pain management strategies and enhance the overall patient experience in dental practice.

Conditions

Discomfort

Keywords

Topical Lidocaine, Infiltration Anesthesia, Tooth Extraction, Injection Pain, Local Anesthesia, Dental Anxiety.

Outcome Measures

Primary Outcomes (2)

• Pain Intensity During Infiltration Injection Assessed by Visual Analogue Scale

  Pain intensity following infiltration injection will be assessed using a 0-10 cm Visual Analogue Scale (VAS) at 5, 15, and 30 minutes after the procedure

  5 minutes, 15 minutes, and 30 minutes post-procedure

• Pain Score (Visual Analogue Scale)

  Pain intensity following infiltration injection will be assessed using a 0-10 cm Visual Analogue Scale (VAS) at 5, 15, and 30 minutes after the procedure.

  5 minutes, 15 minutes, and 30 minutes post-procedure

Study Arms (2)

Arm Type 1: Placebo Comparator (2% lidocaine hydrochloride infiltration injection alone)

PLACEBO COMPARATOR

Arm 1: Control Group Title: 2% lidocaine hydrochloride injection Description: Participants receive conventional 2% lidocaine hydrochloride infiltration anesthesia without prior application of topical lidocaine.

Drug: 2% Lidocaine hydrochloride infiltrate injection

A2: Experimental (5% topical lidocaine hydrochloride preparation+2% lidocaine hydrochloride injecti

EXPERIMENTAL

Arm 2: Experimental Group Title: Topical 5% Lidocaine hydrochloride preparation Plus 2% lidocaine hydrochloride Infiltration injection Description: Participants receive 5% topical lidocaine hydrochloride preparation before administration of 2% lidocaine hydrochloride infiltration injection.

Drug: 2% Lidocaine hydrochloride infiltrate injection; Drug: 5% topical Lidocaine hydrochloride preparation

Interventions

2% Lidocaine hydrochloride infiltrate injection DRUG

Participants assigned to Arm 1 will receive conventional local anesthesia using a 2% lidocaine hydrochloride infiltration injection before tooth extraction. No topical anesthetic will be applied prior to the injection. This arm serves as the control group and represents the standard practice against which the effect of pre-injection topical lidocaine anesthesia will be compared.

A2: Experimental (5% topical lidocaine hydrochloride preparation+2% lidocaine hydrochloride injecti; Arm Type 1: Placebo Comparator (2% lidocaine hydrochloride infiltration injection alone)

5% topical Lidocaine hydrochloride preparation DRUG

Participants assigned to Arm 2 will receive 5% topical lidocaine applied to the mucosal injection site before administration of a 2% lidocaine hydrochloride infiltration injection for tooth extraction. The topical anesthetic is administered as a pre-treatment to reduce pain and discomfort associated with needle insertion and anesthetic infiltration. This arm represents the experimental intervention and will be compared with the control group receiving infiltration anesthesia alone.

A2: Experimental (5% topical lidocaine hydrochloride preparation+2% lidocaine hydrochloride injecti

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 18-65 years of age who underwent extraction of tooth.
• no intolerance or allergies to lidocaine 2% infiltration and lidocaine 5% topical.
• Patients should not take sedative analgesics or anxiety medications in the 12 hour prior to extraction

You may not qualify if:

• Pregnant or lactating women.
• Patient not giving consent to undergo the procedure.
• Patient with occurrence of skin or mucosal allergy or abnormal reaction at the vascular access site.

Sponsors & Collaborators

• Abbasi Shaheed Hospital: lead

Study Sites (1)

Abbasi Shaheed Hospital and Karachi Medical and Dental College

Karachi, Sindh, 74200, Pakistan

Location

Study Officials

• FARWA MUHAMMAD, BACHELOR OF DENTAL SURGERY

  Abbasi Shaheed Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Evaluating the Efficacy of Topical Anesthesia in Alleviating Pain During Infiltrate Injection in Abbasi Shaheed Hospital/KMDC

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: December 1, 2025
• Primary Completion: June 4, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)