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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

We Are Not Studying a Disease or Condition Pain Reduction

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dow Dental College

Karachi, Sindh, Pakistan

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

laser

Other

Low level laser therapy will be used to reduce pain

Benzocaine 20%

Other

20% benzocaine gel to be administered by patient himself

Primary outcomes

mean difference in pain scores

Time frame: from day of separator placement for 7 days

mean difference in pain scores between the two treatments (LLLT and benzocaine gel)

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Apr 30, 2026
Registry last updated: Apr 30, 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.

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Completed