Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| FARWA MUHAMMAD, BACHELOR OF DENTAL SURGERY | Abbasi Shaheed Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbasi Shaheed Hospital and Karachi Medical and Dental College | Karachi | Sindh | 74200 | Pakistan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|