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

NCT ID: NCT06960278

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-05

Study Completion Date

2023-03-02

Brief Summary

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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

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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

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Aphthous Stomatitis, Recurrent Aphthous Stomatitis Aphthous Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

In this study one hundred female, aged between twenty-two and thirty years, reported multiple oral aphthous ulcers. 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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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A Randomized Double-blinded Placebo-controlled Clinical Trial

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

Group Type PLACEBO_COMPARATOR

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

Intervention Type PROCEDURE

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

Control

Intervention Type PROCEDURE

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

Control

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

Control

Intervention Type PROCEDURE

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

Placebo

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

Group Type PLACEBO_COMPARATOR

ALUMSTONE

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type PROCEDURE

Control

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

Intervention Type PROCEDURE

ALUMSTONE

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

22 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Of Anbar

OTHER

Sponsor Role lead

Responsible Party

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Marwan Mahmood Saleh

Marwan Mahmood Saleh

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Iraq, Anbar, Ramadi, 72300

Anbar, Al Anbar, Iraq

Site Status

Countries

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Iraq

Related Links

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Other Identifiers

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UAnbar

Identifier Type: -

Identifier Source: org_study_id

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