Effect of Diode Laser and 20% Benzocaine Anesthetic Gel on Pain Reduction Following Tooth Separation With Elastomeric Separators in Fixed Orthodontic Patients: A Randomized Trial in Karachi-Pakistan

The goal of this clinical trial is to learn if low level laser therapy works equivalent to benzocaine in reducing the pain caused by separators in fixed orthodontic treatment. The main questions it aims to answer are:

Is there any difference in mean pain scores with Low Level Laser Therapy (LLLT) and 20% Benzocaine anesthetic gel of patients receiving elastomeric separators in fixed orthodontic treatment?

Researchers will compare low level laser therapy to benzoaine gel to evaluate reduction in pain

Participants will be applied low level laser at the appointment of separator placement and patient himself will apply benzocaine gel thrice daily at the site of separator placement. patient will use placebo on the other side. Gel and placebo would be applied for one month.

Patient will take the gel for 7 days.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain Reduction; We Are Not Studying a Disease or Condition
• Intervention / Treatment: Other: Benzocaine 20%; Other: Laser

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Dow Dental College

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• - Patient aged 18-25 years
• no history of previous orthodontic treatment
• healthy and complete erupted dentition including permanent second molars
• good periodontal health( on basis of periodontal index)
• Tight proximal contacts of all permanent first molars (both mesially and distally)

Exclusion Criteria:

• - Patients with multiple fillings, root canal treatments, gingivitis,, missing teeth, or spacing between molars and premolars will be excluded from the sample
• Severely rotated teeth
• posterior open bite
• any systematic disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser arm	Other: Benzocaine 20%; 20% benzocaine gel to be administered by patient himself
Active Comparator: benzocaine arm; 20% benzocaine gel to be administered by patient	Other: Laser; Low level laser therapy will be used to reduce pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean difference in pain scores	mean difference in pain scores between the two treatments (LLLT and benzocaine gel)	from day of separator placement for 7 days

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Equipment and Supplies; Optical Devices; Radiation Equipment and Supplies; Lasers
• Other Study ID Numbers: 3957 (Tata Memorial Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No