A Study on Sumac Mouth Rinse for Treating Recurrent Aphthous Stomatitis (SUMAC-RAS)

Ain Shams University

Status: Completed

Conditions: Recurrent Aphthous Stomatitis

Treatments: Drug: Tantum Verde mouth rinse; Other: Sumac mouth rinse

Study type: Interventional

Funder types: Other

Identifiers

NCT07229469

FDASU-ReclM012315

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

38 participants in 2 patient groups

Study group

Experimental group

Description:

Study group receiving sumac mouth rinse

Treatment:

Other: Sumac mouth rinse

Control group

Active Comparator group

Description:

Control group receiving tantum Verde mouth rinse

Treatment:

Drug: Tantum Verde mouth rinse