Aphthous UlcerPhase 4NCT06819033
Effects of Photobiomodulation (PBM) on Pain After Presentation of Aphthous Ulcers in Pediatric Dental Patients
A Phase 4 study testing PBM Therapy and Maalox plus Benadryl in people with Aphthous Ulcer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Aphthous Ulcer
- What is being tested?
- PBM Therapy and Maalox plus Benadryl
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2025to 28 Feb 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient/guardian speaks either English or Spanish
- Patient presenting with one or more aphthous ulcers in their mouth, identified during a scheduled dental appointment
- No previous PBM treatment to the presenting aphthous ulcer(s)
- Guardian able to partake in a follow-up phone call in either the English or Spanish language
Who cannot join
- Patient presents with aphthous ulcers recently treated with PBM
- Patient presents with herpes labialis (cold sores)
- Patients presents with systemic disease that affects soft tissue/mucous healing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Brett Chiquet, DDS, PhD, 713-500-8220, Brett.T.Chiquet@uth.tmc.edu
Jessica Hochschuler, (713) 486-4141, Jessica.L.Hochschuler@uth.tmc.edu
About this study
Official title: Effects of Photobiomodulation on Pain After Presentation of Aphthous Ulcers in Pediatric Dental Patients
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.
- Conditions
- Aphthous Ulcer
- Being tested
- PBM Therapy, Maalox plus Benadryl
- Keywords
- magic mouthwash, laser treatment
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBM TherapyDevice
patients will receive PBM therapy using the Biolase Epic pro laser. An average power of 0.6w (peak power = 80w, rep. rate= 20Hz). Each aphthous ulcer will be irradiated one time for a total of 30 seconds via continuous wave.
Maalox plus BenadrylDrug
1:1 mixture of Maalox and Benadryl will be applied to the ulcer as needed for pain. Applications typically will be applied before eating to form a dissolvable oral band-aid that lasts for up to 30 minutes. 10 milliliters of 1:1 Maalox: Benadryl solution will be provided to the family. During the presenting appointment, the patient/family will be shown how to use the 1:1 Maalox: Benadryl solution. It will be applied topically with no rinsing needed.
| Study group | Role | What they receive |
|---|---|---|
| PBM Therapy | Experimental | Not described Receives: Device: PBM Therapy; Drug: Maalox plus Benadryl |
| Standard of care | Active comparator | Not described Receives: Drug: Maalox plus Benadryl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of life as assessed by questionnaire (Likert scale)
This is a 6 item questionnaire and each is scored from 1-5, maximum score of 30,higher number indicating better outcome
Measured: Baseline, immediately after treatment(about 5 minutes), 24 hours after treatment
Pain as assessed by how frequently patient complains of pain (Likert scale)
Measured: upto 24 hours after treatment
Pain as assessed by number of participants who are using any over-the-counter or prescription medications, topical treatments, or oral rinses to treat aphthous ulcer pain
Measured: upto 24 hours after treatment
Secondary outcomes (3)
Change in lesion size as an indication of healing as assessed by clinical intraoral images of the aphthous ulcer and measuring tool
Measured: pre-treatment and immediately post-treatment(about 5 minutes)
Change in pain as assessed by a Visual Analogue Scale (VAS) for control group
Pain level is scored from 0(no pain) to 10(worst pain)
Measured: Baseline, 24 hours after treatment
Pain as assessed by a Visual Analogue Scale (VAS) for experimental group
Pain level is scored from 0(no pain) to 10(worst pain)
Measured: Baseline, immediately after PBM(about 5 minutes), 24 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start10 Mar 2025
- Primary completion27 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphthous UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett Thomas Chiquet, The University of Texas Health Science Center, Houston
- Investigators
- Brett Chiquet, DDS, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819033
- Sponsor's protocol ID
- HSC-DB-24-1153
- Status last verified
- Mar 2025
- First submitted
- 5 Feb 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photobiomodulation on Pain After Presentation of Aphthous Ulcers in Pediatric Dental Patients
- ClinicalTrials.gov ID
- NCT06819033
- Acronym / sponsor ID
- HSC-DB-24-1153
- Conditions
- Aphthous Ulcer
- Keywords
- magic mouthwash, laser treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 27 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBM Therapy | Experimental | Device: PBM Therapy, Drug: Maalox plus Benadryl |
| Standard of care | Active comparator | Drug: Maalox plus Benadryl |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patient/guardian speaks either English or Spanish
- Patient presenting with one or more aphthous ulcers in their mouth, identified during a scheduled dental appointment
- No previous PBM treatment to the presenting aphthous ulcer(s)
- Guardian able to partake in a follow-up phone call in either the English or Spanish language
Key exclusion criteria (3 listed)
- Patient presents with aphthous ulcers recently treated with PBM
- Patient presents with herpes labialis (cold sores)
- Patients presents with systemic disease that affects soft tissue/mucous healing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBM Therapypatients will receive PBM therapy using the Biolase Epic pro laser. An average power of 0.6w (peak power = 80w, rep. rate= 20Hz). Each aphthous ulcer will be irradiated one time for a total of 30 seconds via continuous wave. | Device | PBM Therapy |
| Maalox plus Benadryl1:1 mixture of Maalox and Benadryl will be applied to the ulcer as needed for pain. Applications typically will be applied before eating to form a dissolvable oral band-aid that lasts for up to 30 minutes. 10 milliliters of 1:1 Maalox: Benadryl solution will be provided to the family. During the presenting appointment, the patient/family will be shown how to use the 1:1 Maalox: Benadryl solution. It will be applied topically with no rinsing needed. | Drug | PBM Therapy, Standard of care |
Primary outcome
Change in Quality of life as assessed by questionnaire (Likert scale)
Time frame: Baseline, immediately after treatment(about 5 minutes), 24 hours after treatment
This is a 6 item questionnaire and each is scored from 1-5, maximum score of 30,higher number indicating better outcome
Pain as assessed by how frequently patient complains of pain (Likert scale)
Time frame: upto 24 hours after treatment
Pain as assessed by number of participants who are using any over-the-counter or prescription medications, topical treatments, or oral rinses to treat aphthous ulcer pain
Time frame: upto 24 hours after treatment
3 secondary outcomes
Change in lesion size as an indication of healing as assessed by clinical intraoral images of the aphthous ulcer and measuring tool
Time frame: pre-treatment and immediately post-treatment(about 5 minutes)
Change in pain as assessed by a Visual Analogue Scale (VAS) for control group
Time frame: Baseline, 24 hours after treatment
Pain as assessed by a Visual Analogue Scale (VAS) for experimental group
Time frame: Baseline, immediately after PBM(about 5 minutes), 24 hours after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brett Chiquet, DDS, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PBM Therapy and Maalox plus Benadryl in people with Aphthous Ulcer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brett Chiquet, DDS, PhD ((713) 500-8220, Brett.T.Chiquet@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of life as assessed by questionnaire (Likert scale) (time frame: Baseline, immediately after treatment(about 5 minutes), 24 hours after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.