Recurrent Aphthous StomatitisSUMAC-RASNCT07229469
A Study on Sumac Mouth Rinse for Treating Recurrent Aphthous Stomatitis
A study testing Sumac mouth rinse and Tantum Verde mouth rinse in people with Recurrent Aphthous Stomatitis, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Aphthous Stomatitis
- What is being tested?
- Sumac mouth rinse and Tantum Verde mouth rinse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2023to 18 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of oral medicine, Faculty of dentistry, Ain Shams university
Cairo, Cairo Governorate, 11517
About this study
Official title: 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.
Read the 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.
- Conditions
- Recurrent Aphthous Stomatitis
- Being tested
- Sumac mouth rinse, Tantum Verde mouth rinse
- Keywords
- Sumac, Rhus coriaria, mouth rinse, recurrent aphthous stomatitis, oral ulcers, TNF-alpha, anti-inflammatory, herbal therapy, clinical trial
- Medical subject headings
- Stomatitis, Aphthous, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sumac mouth rinseOther
Herbal mouth rinse containing Sumac extract
Tantum Verde mouth rinseDrug
Standard mouth rinse according to manufacturer instructions
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Study group receiving sumac mouth rinse Receives: Other: Sumac mouth rinse |
| Control group | Active comparator | Control group receiving tantum Verde mouth rinse Receives: Drug: Tantum Verde mouth rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the baseline / Day 2 / Day 6
Secondary outcomes (2)
Healing index
Healing index included four categories:
- Complete reepithelialization
- Incomplete reepithelialization
- Ulcer
- Tissue defect or necrosis
Measured: 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.
Measured: At the baseline/ Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start20 Dec 2023
- Primary completion25 May 2025
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Aphthous StomatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 , the outcomes assessor and the researcher were blinded to group allocation.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229469
- Sponsor's protocol ID
- FDASU-ReclM012315
- Acronym
- SUMAC-RAS
- Status last verified
- May 2026
- First submitted
- 13 Nov 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sumac Mouth Rinse in the Management of Recurrent Aphthous Stomatitis (A Randomized Controlled Clinical Study With Biochemical Assessment)
- ClinicalTrials.gov ID
- NCT07229469
- Acronym / sponsor ID
- SUMAC-RAS / FDASU-ReclM012315
- Conditions
- Recurrent Aphthous Stomatitis
- Keywords
- Sumac, Rhus coriaria, mouth rinse, recurrent aphthous stomatitis, oral ulcers, TNF-alpha, anti-inflammatory, herbal therapy, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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 , the outcomes assessor and the researcher were blinded to group allocation.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Sumac mouth rinseStudy group receiving sumac mouth rinse |
| Control group | Active comparator | Drug: Tantum Verde mouth rinseControl group receiving tantum Verde mouth rinse |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sumac mouth rinseHerbal mouth rinse containing Sumac extract | Other | Study group |
| Tantum Verde mouth rinseStandard mouth rinse according to manufacturer instructions | Drug | Control group |
Primary outcome
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.
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.
2 secondary outcomes
Healing index
Time frame: At the baseline / Day 2/ Day 6
TNF- alpha
Time frame: At the baseline/ Day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sumac mouth rinse and Tantum Verde mouth rinse in people with Recurrent Aphthous Stomatitis, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (VAS) (time frame: At the baseline / Day 2 / Day 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.