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NCT Number: NCT06960278

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

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.

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Key information

Conditions

Aphthous Stomatitis, Recurrent Aphthous Stomatitis Aphthous Ulcer Mouth Diseases Stomatitis Stomatitis, Aphthous Stomatognathic Diseases Sutton disease 2

Age range

22 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Iraq, Anbar, Ramadi, 72300

Anbar, Al-Anbar Governorate, 72300, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

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

Procedure

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

Control

Procedure

The dimensions of the lesion were measured by oral medicine specialists using a flexible ruler

ALUMSTONE

Device

alum administration via adhesive patches on the healing process of aphthous ulcers

Primary outcomes

  1. Lesion Size

    Time frame: 1, 3, 5 day

Sponsors and collaborators

Lead sponsor

University Of Anbar

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 7, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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