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

Sumac Mouth Rinse in the Management of Recurrent Aphthous Stomatitis (A Randomized Controlled Clinical Study With Biochemical Assessment)

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Aphthous Stomatitis
• Intervention / Treatment: Other: Sumac mouth rinse; Drug: Tantum Verde mouth rinse

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11517
      • Department of oral medicine, Faculty of dentistry, Ain Shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; Study group receiving sumac mouth rinse	Other: Sumac mouth rinse; Herbal mouth rinse containing Sumac extract
Active Comparator: Control group; Control group receiving tantum Verde mouth rinse	Drug: Tantum Verde mouth rinse; Standard mouth rinse according to manufacturer instructions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At the baseline / Day 2 / Day 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing index	Healing index included four categories: Complete reepithelialization; Incomplete reepithelialization; Ulcer; Tissue defect or necrosis	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.	At the baseline/ Day 6

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Actual): May 25, 2025
• Study Completion (Actual): August 18, 2025

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Sumac, Rhus coriaria, mouth rinse, recurrent aphthous stomatitis, oral ulcers, TNF-alpha, anti-inflammatory, herbal therapy, clinical trial
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Stomatitis; Oral Ulcer; Stomatitis, Aphthous
• Other Study ID Numbers: FDASU-ReclM012315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No