PBM Therapy for Canker Sores

Overseen By Jessica Hochschuler

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Herpes labialis, Systemic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Maalox plus Benadryl, PBM Therapy for canker sores?

Research shows that photobiomodulation (PBM) therapy is effective in reducing pain and healing time for oral conditions like oral mucositis and recurrent aphthous stomatitis (canker sores), suggesting it may help with canker sores as well. ^{1 2 3 4 5}

How does PBM Therapy differ from other treatments for canker sores?

PBM Therapy is unique because it uses low-intensity laser light to promote healing and reduce pain, unlike traditional treatments that may rely on topical ointments or oral medications. This therapy is non-invasive and has been shown to be effective in reducing pain and improving healing in conditions like oral mucositis, which is similar to canker sores. ^{3 5 6 7 8}

What is the purpose of this trial?

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 ulcers , to assess how photobiomodulation influences the rate of healing of aphthous ulcers in pediatric patients and to measure changes in pain levels reported by pediatric patients undergoing photobiomodulation treatment for aphthous ulcers.

Research Team

Brett Chiquet, DDS, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

Group I: PBM Therapy Experimental Treatment 2 Interventions

Group II: Standard of care Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-power laser photobiomodulation therapy for immediate pain relief of refractory oral mucositis. Finfter, O., Cohen, R., Hanut, A., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Locally advanced oral squamous cell carcinoma patients treated with photobiomodulation for prevention of oral mucositis: retrospective outcomes and safety analyses. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Photobiomodulation in Pain Control in Diseases of the Oral Cavity: Overview (Evidence Map) and Its Implementation in Integrative Complementary Medicine. [2022]

3. Denmark pubmed.ncbi.nlm.nih.gov

High-power laser photobiomodulation therapy for immediate pain relief of refractory oral mucositis. [2023]

4. Spain pubmed.ncbi.nlm.nih.gov

Photobiomodulation therapy for the management of recurrent aphthous stomatitis in children: clinical effectiveness and parental satisfaction. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Twenty-year analysis of photobiomodulation clinical studies for oral mucositis: a scoping review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Photobiomodulation Therapy in Cancer Patients with Mucositis: A Clinical Evaluation. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Effectiveness of photobiomodulation in the treatment of primary burning mouth syndrome-a systematic review and meta-analysis. [2021]

8. Spain pubmed.ncbi.nlm.nih.gov

Therapeutic Outcomes of Photobiomodulation in Cancer Treatment-induced Oral Mucositis: A Systematic Review. [2023]