A Study on Sumac Mouth Rinse for Treating Recurrent Aphth... | NCT07229469

Studies
A Study on Sumac Mouth Rinse for Treating Recurrent Aphthous Stomatitis

NCT07229469

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

May 8, 2026Actual

Enrollment

38Actual

Phase

Not Applicable

Conditions

Recurrent Aphthous Stomatitis

Interventions

Sumac mouth rinse
Tantum Verde mouth rinse

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2023Actual

Primary Completion Date

May 25, 2025Actual

Completion Date

Aug 18, 2025Actual

First Submitted Date

Nov 13, 2025

First Submission Date that Met QC Criteria

Nov 13, 2025

First Posted Date

Nov 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2026

Last Update Posted Date

May 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Sumac mouth rinse	Other	Herbal mouth rinse containing Sumac extract	Study group

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of oral medicine, Faculty of dentistry, Ain Shams university		Cairo	Cairo Governorate	11517	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013281	Stomatitis, Aphthous
D019226	Oral Ulcer

Ancestor Terms

ID	Term
D013280	Stomatitis
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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 Info

Masking

Triple

Masking Description

Both participants the outcomes assessor and the researcher were blinded to the treatment allocation. The Sumac mouth rinse and placebo were identical in appearance, color, and packaging and were stored in amber bottles to maintain blinding throughout the study.

Who Masked

ParticipantInvestigatorOutcomes Assessor