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The search for methods that can shorten the treatment process of aphthous ulcers, the etiology of which is not fully understood, continues. The aim of this study was to determine whether photodynamic therapy (PDT) is a clinically effective alternative in the treatment of oral aphthous ulcers.
After sample size calculation, photodynamic therapy and control groups were formed with 15 patients with aphthous ulcer in each group. Laser therapy with indocyanine green was applied to the photodynamic therapy group on the day they were admitted to the clinic. No treatment was performed in the control group and only follow-up was performed. Lesion diameters, pain intensity and degree of improvement at the end of 1 week were recorded in all patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photodynamic Therapy (PDT) Group | Experimental | Patients in the PDT group were treated in a single session on the day of admission to the clinic. Indocyanine green (Perio green, Elexxion AG, Radolfzell, Germany) prepared and applied according to manufacturer's instructions steps (mixing, application, soaking phase, rinsing, activation) in a concentration with 0.1mg/mL was administered via fine-needle syringe as the photosensitizer. Following the completion of topical application of the photosensitizer to the lesion surface, a (GaAlAs) diode laser device (Cheese Diode Laser, Wuhan Gigaa Optronics Technology Co. Ltd, China) in continuous mode (810 nm, 300 mW, 10,000 kHz, 1.26 cm2 spot area), with a 400 μm polymethylmethacrylate optical fiber tip, scanning from the periphery to the center of the lesion with an energy density of approximately 10 J/cm2 for 40 s and applied non-contact at a distance of 1 mm. |
|
| Control Group | No Intervention | The lesions of the patients in the control group were not treated but only followed up. Recommendations were made to reduce their pain (avoidance of hot, spicy and acidic foods, attention to oral hygiene, etc.) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photodynamic therapy (indocyanine green+laser) | Combination Product | Photodynamic therapy with indocyanine green |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ulcer wound healing with diameter measurement | Lesion diameters were measured with a elastic ruler and the healing rate of the lesion was monitored. | One week (preoperatively and on postoperative days 3, 5 and 7 ) |
| Level of recovery | A 3-point scale was used. Grade 1 represents "complete recovery", Grade 2 represents "moderate recovery", Grade 3 represents "little recovery". | Postoperatively 7 th day |
| Measure | Description | Time Frame |
|---|---|---|
| Pain evaluation with Visual Analogue Scale | For lesion-related pain follow-up, patients in the PDT group were asked to score the pain they felt on VAS on preoperative, 1st, 3rd, 5th and 7th days. VAS measurements of the patients in the control group were made on days 1, 3, 5 and 7. | One week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cennet N Eroglu, DDS,PhD | Yuzuncu Yil University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuzuncu Yil University | Van | Merkez | 65080 | Turkey (Türkiye) |
After the study published, the study information will be shared with the researchers who request it, taking into account the right to protect personal data.
IPD and documents will be available for sharing 1 year after publication for a period of 2 years. Access to the IPD and documenta will be open on the IPDShare website with registration. The information will be freely available and can be used for any purpose. There will not be any review process or no Data Use Agreement will be necessary.
IPD and documents will be available for sharing 1 year after publication for a period of 2 years. Access to the IPD and documenta will be open on the IPDShare website with registration. The information will be freely available and can be used for any purpose. There will not be any review process or no Data Use Agreement will be necessary.
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| ID | Term |
|---|---|
| D019226 | Oral Ulcer |
| D013281 | Stomatitis, Aphthous |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D013280 | Stomatitis |
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| ID | Term |
|---|---|
| D010778 | Photochemotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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