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

NCT06960278 | Completed Early Phase 1 DMC

• 1 other identifier: UAnbar
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aphthous Stomatitis, Recurrent; Aphthous Stomatitis; Aphthous Ulcer

Keywords

Alum stone; aphthous ulcer; mucosal adhesive patches

Outcome Measures

Primary Outcomes (1)

• Lesion Size

  1, 3, 5 day

Study Arms (3)

A Randomized Double-blinded Placebo-controlled Clinical Trial

PLACEBO COMPARATOR

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

Control

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Device: ALUMSTONE

Interventions

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.

A Randomized Double-blinded Placebo-controlled Clinical Trial; Control

Control PROCEDURE

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

A Randomized Double-blinded Placebo-controlled Clinical Trial; Control

ALUMSTONE DEVICE

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

Placebo

Eligibility Criteria

• Age: 22 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• University Of Anbar: lead

Study Sites (1)

Iraq, Anbar, Ramadi, 72300

Anbar, Al-Anbar Governorate, 72300, Iraq

Location

Related Links

• Related Info
• Related Info
• Related Info

MeSH Terms

Conditions

Sutton disease 2; Stomatitis, Aphthous

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marwan Mahmood Saleh

Model Details: 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

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: May 7, 2025
• Study Start: February 5, 2021
• Primary Completion: October 15, 2022
• Study Completion: March 2, 2023
• Last Updated: May 7, 2025

Record last verified: 2025-04

Locations

IR (1)