An interventional study of Sumac mouth rinse and Tantum Verde mouth rinse in Recurrent Aphthous Stomatitis, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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.
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's enrollment of 38 is close to the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study group receiving sumac mouth rinse
Other: Sumac mouth rinse
Control group receiving tantum Verde mouth rinse
Drug: Tantum Verde mouth rinse
Herbal mouth rinse containing Sumac extract
Standard mouth rinse according to manufacturer instructions
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
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
Plan to share: Undecided
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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