A Study on Sumac Mouth Rinse for Treating Recurrent Aphthous Stomatitis

NCT07229469 | Completed

• 1 other identifier: FDASU-ReclM012315
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Aphthous Stomatitis

Keywords

Sumac, Rhus coriaria, mouth rinse, recurrent aphthous stomatitis, oral ulcers, TNF-alpha, anti-inflammatory, herbal therapy, clinical trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Healing index

  At the baseline / Day 2/ Day 6

• TNF- alpha

  At the baseline/ Day 6

Study Arms (2)

Study group

EXPERIMENTAL

Study group receiving sumac mouth rinse

Other: Sumac mouth rinse

Control group

ACTIVE COMPARATOR

Control group receiving tantum Verde mouth rinse

Drug: Tantum Verde mouth rinse

Interventions

Sumac mouth rinse OTHER

Herbal mouth rinse containing Sumac extract

Study group

Tantum Verde mouth rinse DRUG

Standard mouth rinse according to manufacturer instructions

Control group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

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

Cairo, Cairo Governorate, 11517, Egypt

Location

MeSH Terms

Conditions

Stomatitis, Aphthous; Oral Ulcer

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both participants and the outcomes assessor were blinded to the treatment allocation. The Sumac mouth rinse and placebo were identical in appearance, color, and packaging to maintain blinding throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A parallel, randomized controlled clinical trial with two groups: one group received Sumac mouth rinse and the control group received Tantum Verde mouth rinse . Participants were randomly assigned to each group. Both participants and the outcomes assessor were blinded to group allocation.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: December 20, 2023
• Primary Completion: May 25, 2025
• Study Completion: August 18, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-10

Locations

EG (1)