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

University Of Anbar

Status and phase

Completed

Early Phase 1

Conditions

Aphthous Stomatitis

Aphthous Ulcer

Aphthous Stomatitis, Recurrent

Treatments

Device: ALUMSTONE

Procedure: Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5.

Procedure: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT06960278

UAnbar

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

Female

Ages

22 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

100 participants in 3 patient groups, including a placebo group

A Randomized Double-blinded Placebo-controlled Clinical Trial

Placebo Comparator group

Description:

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

Treatment:

Procedure: Control

Procedure: Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5.

Control

Experimental group

Treatment:

Procedure: Control

Procedure: Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5.

Placebo

Placebo Comparator group

Description:

hundred female from the patients of oral diagnosis clinic in college of dentistry and from the privet clinic