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

Evaluating the Efficacy of Topical Anesthesia in Alleviating Pain During Infiltrate Injection in Abbasi Shaheed Hospital/KMDC

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Discomfort
• Intervention / Treatment: Drug: 2% Lidocaine hydrochloride infiltrate injection; Drug: 5% topical Lidocaine hydrochloride preparation

Detailed Description

This randomized clinical trial is designed to evaluate the effectiveness of 5% topical lidocaine in reducing pain associated with infiltration anesthesia in patients undergoing tooth extraction. Pain during local anesthetic administration remains a common cause of anxiety and fear among dental patients and may negatively affect treatment acceptance, patient cooperation, and overall clinical experience.

The study will be conducted at the Department of Oral and Maxillofacial Surgery, Abbasi Shaheed Hospital, and the Department of Oral Surgery, KMDC. A total of 120 eligible adult patients requiring tooth extraction will be recruited after obtaining informed consent. Participants will be randomly allocated into two groups using sealed opaque envelopes. Group A will receive conventional infiltration anesthesia with 2% lidocaine alone, while Group B will receive 5% topical lidocaine prior to administration of 2% lidocaine infiltration anesthesia.

The primary outcome measure will be pain intensity, assessed using the Visual Analogue Scale (VAS). Pain scores will be recorded at 5, 15, and 30 minutes following the procedure. Relevant demographic and clinical variables, including age, gender, smoking status, diabetes mellitus, and hypertension, will also be collected to evaluate potential confounding factors.

The intervention poses minimal risk to participants, as both topical and infiltrative lidocaine are routinely used and well-established agents in dental practice. Patients with known allergies to lidocaine, pregnant or lactating women, and individuals unwilling to participate will be excluded to ensure participant safety. All participants will receive the standard of care required for tooth extraction irrespective of study allocation.

The anticipated benefit of this study is the generation of evidence regarding the effectiveness of topical anesthesia as an adjunctive measure for reducing injection-related pain. The findings may contribute to improved patient comfort, reduced anxiety, enhanced treatment acceptance, and optimization of pain management protocols in routine dental practice.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Abbasi Shaheed Hospital and Karachi Medical and Dental College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm Type 1: Placebo Comparator (2% lidocaine hydrochloride infiltration injection alone); 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; 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.
Experimental: A2: Experimental (5% topical lidocaine hydrochloride preparation+2% lidocaine hydrochloride injecti; 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; 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.; Drug: 5% topical Lidocaine hydrochloride preparation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbasi Shaheed Hospital
• Investigators: Principal Investigator: FARWA MUHAMMAD, BACHELOR OF DENTAL SURGERY, Abbasi Shaheed Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Actual): June 4, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Topical Lidocaine, Infiltration Anesthesia, Tooth Extraction, Injection Pain, Local Anesthesia, Dental Anxiety.
• Other Study ID Numbers: IRB/KMDC/KMU/26/2025

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