An Early Phase 1 interventional study of Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5. and Control in Aphthous Stomatitis, Recurrent, Aphthous Stomatitis and Aphthous Ulcer, sponsored by University Of Anbar. Completed at 1 site in Iraq. Open to female participants aged 22 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by University Of Anbar · Early Phase 1, Interventional, and Treatment
The evaluation of recurrent aphthous stomatitis (RAS) was performed by an oral medicine specialist, who relied on the clinical manifestations of the condition. The experimental group was administered 1x1cm mucosal patches containing alum stone at a concentration of 7%, whereas the control group was given placebo patches without any active medication. Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5. Statistical analysis was performed with repeated measures ANOVA using R software.
The study's results indicated that the utilization of alum stone in mucosal adhesive patches yielded significant reductions in size of aphthous lesions and degree of pain.
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's enrollment of 100 is above the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →University Of Anbar is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Inclusion Criteria: individuals who had a history of RAS, with oral ulceration occurring at least once a month and persistent oral ulceration being present in the majority of patients. Additionally, individuals with mild aphthous ulcer, characterized by ulcer development lasting fewer than three days, were also included.
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Exclusion Criteria: Exclusion criteria encompassed the following: Pregnancy or lactation, systemic disorders linked to aphthous ulcers, such as Crohn's disease, Reiter's syndrome, and people who smoke or use cigarettes. Participants who were getting pharmacological therapy for fungal or viral infections, as well as those who were taking non-steroidal anti-inflammatory drugs, subjects with recent oral surgery, and those with fixed orthodontic appliances or retainers near the ulcer were not recruited for the study
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The experimental group was administered 1x1cm mucosal patches containing alum stone at a concentration of 7%, whereas the control group was given placebo patches without any active medication
Procedure: Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5. · Procedure: Control
Procedure: Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5. · Procedure: Control
hundred female from the patients of oral diagnosis clinic in college of dentistry and from the privet clinic
Device: ALUMSTONE
Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5.
The dimensions of the lesion were measured by oral medicine specialists using a flexible ruler
alum administration via adhesive patches on the healing process of aphthous ulcers
Lesion Size
Time frame: 1, 3, 5 day
Ran from Feb 2021 to primary completion in Oct 2022, 20 months.
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University Of Anbar