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Photobiomodulation for Pain After Root Canal Surgery

N/A

Recruiting

Led By Juliana Barros, DDS,MS

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

American Society of Anesthesiologists (ASA) I or II

Be older than 18 years old

Must not have

ASA III or IV

Current heavy smokers (>10 cigarettes/day)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preoperative assessment (baseline), immediately after surgery, and 5-7 days post-surgery during the sutures removal appointment

Summary

This trial aims to see if using Photobiomodulation (PBM) can help reduce pain after a specific dental surgery at the University of Texas Health Science Center. Researchers also want to see how

Who is the study for?

This trial is for patients at the University of Texas Health Science Center's School of Dentistry who are undergoing endodontic microsurgery (EMS) for various dental pulp and periapical diseases. Participants should be in need of EMS due to conditions like gum disease or nonvital teeth.

What is being tested?

The study is testing the effectiveness of Photobiomodulation (PBM), a light therapy, on reducing pain and improving healing after EMS. Patients will receive either actual PBM treatment or a sham (placebo) version to compare outcomes.

What are the potential side effects?

Since PBM involves using light without heat, it's generally considered safe with minimal risks. Side effects might include slight discomfort during treatment but significant adverse effects are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am in good or mild systemic disease condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious but not life-threatening health condition.

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I currently smoke more than 10 cigarettes a day.

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My diabetes or other systemic diseases are not under control.

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I can have surgery through the roof of my mouth.

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I have swelling or an abscess on the day of my surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ preoperative assessment (baseline), immediately after surgery, and 5-7 days post-surgery during the sutures removal appointment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~preoperative assessment (baseline), immediately after surgery, and 5-7 days post-surgery during the sutures removal appointment

This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative assessment (baseline), immediately after surgery, and 5-7 days post-surgery during the sutures removal appointment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in pain as assessed by a Visual Analogue Scale (VAS)

Secondary study objectives

Change in healing as assessed by the Early Wound Healing Score (EHS).

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EMS and PBM treatmentExperimental Treatment2 Interventions

Photobiomodulation (PBM) therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, North Carolina, USA) following the outline of the incision flap in a contact mode. Each site will be irradiated for 25 seconds with an energy density of 10 J/cm2 (irradiation mode).

Group II: EMS and PBM sham treatmentPlacebo Group2 Interventions

The laser tip will be placed following the outline of the incision flap in a contact mode but without activating it (no irradiation).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EMS

2023

N/A

~230

0 / 6Eligibility criteria met