A Study on Sumac Mouth Rinse for Treating Recurrent Aphthous Stomatitis

Ain Shams University38 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Recurrent Aphthous Stomatitis

Interventions

Sumac mouth rinseOTHER

Herbal mouth rinse containing Sumac extract

Tantum Verde mouth rinseDRUG

Standard mouth rinse according to manufacturer instructions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

Pain (VAS)

Visual Analog Scale (VAS) to assess the intensity of oral ulcer pain reported by the patient, where 0 indicates no pain and 10 indicates the worst imaginable pain.

Time frame: At the baseline / Day 2 / Day 6

Ulcer size

Measurement of the oral ulcer diameter in millimeters using a ruler or photographic analysis to evaluate ulcer size reduction over time.

Time frame: At the baseline / Day 2 / Day 6

Secondary Outcomes

Healing index

Healing index included four categories: 1. Complete reepithelialization 2. Incomplete reepithelialization 3. Ulcer 4. Tissue defect or necrosis

Time frame: At the baseline / Day 2/ Day 6

TNF- alpha

Quantification of the inflammatory cytokine TNF-α in blood or saliva using ELISA to evaluate the inflammatory response associated with oral ulcers.

Time frame: At the baseline/ Day 6

Data from ClinicalTrials.gov

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