NCT06960278

Effect of Alum Stone Containing Mucosal Adhesive Patches on Healing of Recurrent Aphthous Stomatitis

Effect of Alum Stone Containing Mucosal Adhesive Patches on Healing of Recurrent Aphthous Stomatitis: A Randomized Double-blinded Placebo-controlled Clinical Trial

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University Of Anbar · Academic / Other
• Sex: Female
• Age: 22 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Aphthous Stomatitis, Recurrent
• Aphthous Stomatitis
• Aphthous Ulcer

Interventions

Type	Name	Description
PROCEDURE	Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5.	Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5.
PROCEDURE	Control	The dimensions of the lesion were measured by oral medicine specialists using a flexible ruler
DEVICE	ALUMSTONE	alum administration via adhesive patches on the healing process of aphthous ulcers

Timeline

• Start date: 2021-02-05
• Primary completion: 2022-10-15
• Completion: 2023-03-02
• First posted: 2025-05-07
• Last updated: 2025-05-07

Locations

1 site across 1 country: Iraq