A Study on Sumac Mouth Rinse for Treating Recurrent Aphthous Stomatitis

NCT ID: NCT07229469

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2025-08-18

Brief Summary

This randomized controlled clinical study aims to evaluate the effectiveness of a Sumac mouth rinse in the management of recurrent aphthous stomatitis (RAS). In addition to assessing clinical improvement in ulcer healing and pain reduction, biochemical analysis will be performed by measuring serum TNF-α levels to evaluate the anti-inflammatory effect of Sumac.

Detailed Description

Recurrent aphthous stomatitis (RAS) is one of the most common oral mucosal disorders, characterized by recurrent, painful ulcers that interfere with eating and speaking. The etiology of RAS is multifactorial and involves immune dysregulation and increased levels of inflammatory cytokines, particularly tumor necrosis factor-alpha (TNF-α).

Sumac (Rhus coriaria) is a natural herbal extract known for its anti-inflammatory, antioxidant, and antimicrobial properties. This randomized controlled clinical study aims to evaluate the clinical effectiveness of a Sumac mouth rinse in promoting ulcer healing and reducing pain among patients with recurrent aphthous stomatitis.

In addition to clinical assessment, biochemical evaluation of serum TNF-α levels will be performed before and after treatment to investigate the possible anti-inflammatory mechanism of Sumac. The study findings are expected to provide new insights into the potential therapeutic role of Sumac in managing RAS.

Conditions

Recurrent Aphthous Stomatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study group

Study group receiving sumac mouth rinse

Group Type: EXPERIMENTAL

Sumac mouth rinse

Intervention Type: OTHER

Herbal mouth rinse containing Sumac extract

Control group

Control group receiving tantum Verde mouth rinse

Group Type: ACTIVE_COMPARATOR

Tantum Verde mouth rinse

Intervention Type: DRUG

Standard mouth rinse according to manufacturer instructions

Interventions

Sumac mouth rinse

Herbal mouth rinse containing Sumac extract

Intervention Type: OTHER

Tantum Verde mouth rinse

Standard mouth rinse according to manufacturer instructions

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients aged 18 years or older
• Systemically healthy
• Patients with recurrent aphthous stomatitis minor type
• Duration of ulcer does not exceed 2 days
• Oral pain score of 4 or higher on the Visual Analog Scale (VAS)

Exclusion Criteria

• Patients with poor oral hygiene
• Smokers and alcohol users
• Pregnant or lactating females
• Patients with a history of any topical or systemic medication or steroid therapy within 1 month prior to the study
• Vulnerable populations such as prisoners or individuals with mental or physical disabilities

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of oral medicine, Faculty of dentistry, Ain Shams university

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

FDASU-ReclM012315

Identifier Type: -

Identifier Source: org_study_id