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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser arm | Experimental |
| |
| benzocaine arm | Active Comparator | 20% benzocaine gel to be administered by patient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser | Other | Low level laser therapy will be used to reduce pain |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dow Dental College | Karachi | Sindh | Pakistan |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2025 |
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| Benzocaine 20% |
| Other |
20% benzocaine gel to be administered by patient himself |
|
| Apr 27, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 27, 2026 | Apr 27, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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