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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBM Therapy | Experimental |
| |
| Standard of care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBM Therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, immediately after treatment(about 5 minutes), 24 hours after treatment |
| Pain as assessed by how frequently patient complains of pain (Likert scale) | 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 | upto 24 hours after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lesion size as an indication of healing as assessed by clinical intraoral images of the aphthous ulcer and measuring tool | pre-treatment and immediately post-treatment(about 5 minutes) | |
| Change in pain as assessed by a Visual Analogue Scale (VAS) for control group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brett Chiquet, DDS, PhD | Contact | (713) 500-8220 | Brett.T.Chiquet@uth.tmc.edu | |
| Jessica Hochschuler | Contact | (713) 486-4141 | Jessica.L.Hochschuler@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brett Chiquet, DDS, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D013281 | Stomatitis, Aphthous |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| C013591 | aluminum hydroxide, magnesium hydroxide, drug combination |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
| D005021 | Ethylamines |
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| Maalox plus Benadryl | Drug | 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. |
|
Pain level is scored from 0(no pain) to 10(worst pain)
| 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) | Baseline, immediately after PBM(about 5 minutes), 24 hours after treatment |
| D000588 |
| Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |