Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07707557

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Abbasi Shaheed Hospital and Karachi Medical and Dental College

Karachi, Sindh, 74200, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain Intensity During Infiltration Injection Assessed by Visual Analogue Scale

    Time frame: 5 minutes, 15 minutes, and 30 minutes post-procedure

    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

  2. Pain Score (Visual Analogue Scale)

    Time frame: 5 minutes, 15 minutes, and 30 minutes post-procedure

    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.

Sponsors and collaborators

Lead sponsor

Abbasi Shaheed Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

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.

Published trials that share one or more normalized conditions with this study.