30 Participants Needed

PBM Therapy for Canker Sores

BC
JH
Overseen ByJessica Hochschuler
Age: < 18
Sex: Any
Trial Phase: Phase 4
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for canker sores in children: laser photobiomodulation (PBM) therapy and Magic Mouthwash. It aims to determine which treatment better eases pain, speeds healing, and improves comfort. Children with canker sores identified during a dental visit, who have not tried PBM before, and whose guardians speak English or Spanish, may be suitable candidates. The goal is to discover if laser treatment significantly improves healing and pain relief compared to standard care. As a Phase 4 trial, this research explores how these FDA-approved treatments can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for these treatments?

Research has shown that PBM (photobiomodulation) therapy is generally safe for oral health treatments. Studies have found that this light therapy, which does not use heat, can reduce pain and swelling without causing major side effects. Notably, no reports of serious problems have emerged in patients using PBM for oral issues. Patients usually tolerate it well, experiencing little to no discomfort during or after treatment. This makes PBM an attractive option for managing pain in conditions like canker sores.12345

Why are researchers enthusiastic about this study treatment?

Photobiomodulation (PBM) therapy is unique because it uses light to stimulate healing in canker sores, unlike standard treatments that typically involve topical steroids or antiseptic mouthwashes. This non-invasive approach targets the source of pain and inflammation directly, potentially speeding up recovery without the side effects associated with medication. Researchers are excited about PBM therapy because it offers a novel mechanism of action by enhancing cellular repair and reducing discomfort more rapidly than conventional options. Plus, it could provide a new avenue for those who don't respond well to traditional treatments.

What evidence suggests that PBM Therapy is effective for canker sores?

Studies have shown that light therapy, known as photobiomodulation (PBM), effectively reduces pain from mouth sores like canker sores. One study found that 90% of participants experienced pain relief by the third day of PBM treatment. Another study demonstrated that a specific type of PBM laser provided immediate pain relief and accelerated sore healing. In this trial, participants will receive either PBM therapy or standard care. These findings suggest that PBM therapy could be a promising option for managing pain and speeding up the healing of canker sores in children.46789

Who Is on the Research Team?

BC

Brett Chiquet, DDS, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for pediatric dental patients who are experiencing pain from canker sores. The study aims to include those who could benefit from treatments aimed at reducing discomfort and speeding up healing.

Inclusion Criteria

I haven't had PBM treatment for my current mouth ulcers.
I have one or more canker sores in my mouth, found during a dental check-up.
My guardian can speak English or Spanish for follow-up calls.

Exclusion Criteria

I recently had treatment for mouth sores with light therapy.
I have cold sores.
I have a condition that affects my body's ability to heal soft tissue or mucous.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either laser photobiomodulation or 'Magic Mouthwash' for treatment of pain in aphthous ulcers

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in pain levels and quality of life after treatment

24 hours
1 follow-up assessment (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Maalox plus Benadryl
  • PBM Therapy
Trial Overview The trial is testing the effectiveness of laser photobiomodulation (PBM) therapy against 'Magic Mouthwash' (Maalox plus Benadryl) in managing pain and promoting healing in children with aphthous ulcers.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: PBM TherapyExperimental Treatment2 Interventions
Group II: Standard of careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

Published Research Related to This Trial

High-power laser photobiomodulation (PBM) therapy significantly reduced pain in 25 cancer patients with refractory oral mucositis, with 94% of treatment sessions resulting in immediate pain relief.
Patients experienced an average pain reduction of 72% for chemotherapy-induced mucositis and 60% for radiotherapy-induced mucositis, with effects lasting around 6 days, indicating PBM as a safe and effective non-drug option for pain management.
High-power laser photobiomodulation therapy for immediate pain relief of refractory oral mucositis.Finfter, O., Cohen, R., Hanut, A., et al.[2023]

Citations

Effectiveness of Photobiomodulation in Reducing Pain ...PBM can be a useful adjunctive treatment to relieve the pain of oral mucosal diseases due to its ability to reduce pain intensity.
Effects of Photobiomodulation (PBM) on Pain After ...The purpose of this study is to compare the efficacy of laser photobiomodulation and "Magic Mouthwash" for treatment of pain in pediatric patients with aphthous ...
Photobiomodulation therapy for the management of ...Estimating that there is a success percentage of 90 % on day 3 for the group treated through PBMT by laser and of 50 % for the control group, the minimum number ...
A Novel Therapeutic Approach of 980 nm ...A ฮป 980 nm PBM laser delivered with a flattop hand-piece showed to be effective in offering an immediate pain relief and rapid complete ulcer resolution with no ...
Effects of Photobiomodulation (PBM) on Pain After ... - MedPathThe purpose of this study is to compare the efficacy of laser photobiomodulation and "Magic Mouthwash" for treatment of pain in pediatric patient...
PHOTOBIOMODULATION (PBM) IN ORAL HEALTHThis non-thermal and non-surgical light treatment has been noted to reduce pain or inflammation, modulate immune responses, and promote tissue healing and ...
Efficacy and safety of photobiomodulation combined with oral ...Although PBM and OCT are safe and effective and abundant scientific evidence has demonstrated that both therapies significantly reduce pain or ...
Photobiomodulation Therapy in Oral Medicine: A Guide for ...The application of PBM associated or not to the traditional topical therapies may improve the pain and the clinical signs without complications or side effects; ...
Effectiveness of Photobiomodulation in Reducing Pain ...PBM can be a useful adjunctive treatment to relieve the pain of oral mucosal diseases due to its ability to reduce pain intensity.
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