Clinical trial

Treatment of Aphtous Ulcers With Photodynamic Therapy: A Randomised Controlled Clinical Trial

Name
06/16022018
Description
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.
Trial arms
Trial start
2018-03-05
Estimated PCD
2019-03-01
Trial end
2019-03-08
Status
Completed
Treatment
Photodynamic therapy (indocyanine green+laser)
Photodynamic therapy with indocyanine green
Arms:
Photodynamic Therapy (PDT) Group
Size
30
Primary endpoint
Ulcer wound healing with diameter measurement
One week (preoperatively and on postoperative days 3, 5 and 7 )
Level of recovery
Postoperatively 7 th day
Eligibility criteria
Inclusion Criteria: * ASA-1 patients without any systemic disease, * With a history of canker sores not exceeding 2 days, * Not taking any antibiotics or anti-inflammatory drugs. Exclusion Criteria: * Laser therapy contraindicated, * Pregnancy, * Smoking habbit, * Poor oral hygiene, * Patients under 18 years of age
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2024-04-23

1 organization

1 product

2 indications

Indication
Oral Ulcer