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

NCT07558720 | Active Not Recruiting

• 1 other identifier: 3957
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Reduction; We Are Not Studying a Disease or Condition

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Laser arm

EXPERIMENTAL

Other: Benzocaine 20%

benzocaine arm

ACTIVE COMPARATOR

20% benzocaine gel to be administered by patient

Other: Laser

Interventions

Laser OTHER

Low level laser therapy will be used to reduce pain

benzocaine arm

Benzocaine 20% OTHER

20% benzocaine gel to be administered by patient himself

Laser arm

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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)

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow Dental College

Karachi, Sindh, Pakistan

Location

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Docter

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: April 30, 2026
• Study Start: December 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

PA (1)