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NCT Number: NCT07229469

A Study on Sumac Mouth Rinse for Treating Recurrent Aphthous Stomatitis

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.

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Key information

Conditions

Recurrent Aphthous Stomatitis Mouth Diseases Oral Ulcer Stomatitis Stomatitis, Aphthous Stomatognathic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, Cairo Governorate, 11517, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sumac mouth rinse

Other

Herbal mouth rinse containing Sumac extract

Tantum Verde mouth rinse

Drug

Standard mouth rinse according to manufacturer instructions

Primary outcomes

  1. Pain (VAS)

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

    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.

  2. Ulcer size

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

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

Secondary outcomes

  1. Healing index

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

    Healing index included four categories:

    • Complete reepithelialization
    • Incomplete reepithelialization
    • Ulcer
    • Tissue defect or necrosis

  2. TNF- alpha

    Time frame: At the baseline/ Day 6

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: SUMAC-RAS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 17, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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