NCT07853326

Brief Summary

Oral recurrent aphthous stomatitis is a painful oral condition that affects large number of patients. In the Middle East, patients tend to commonly manage it by sesame paste. So, this study aims to test if sesame paste has any medical value compared to placebo.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Dec 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 26, 2026

Last Update Submit

September 26, 2026

Conditions

Recurrent Aphthous Stomatitis

Outcome Measures

Primary Outcomes (1)

  • Pain due to the oral ulcer

    measured by VAS

    7 days

Secondary Outcomes (1)

  • Size of the ulcer

    7 days

Study Arms (2)

Sesame paste

ACTIVE COMPARATOR
Dietary Supplement: Sesame paste

Placebo paste

PLACEBO COMPARATOR
Other: Placebo

Interventions

Sesame pasteDIETARY_SUPPLEMENT

Sesame paste is available in grocery markets as "Tahina" or "Tahini"

Sesame paste
PlaceboOTHER

placebo paste made to look, feel and smell like sesame paste

Placebo paste

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- adult patients; diagnosed with having episodes of minor recurrent aphthous stomatitis around the age of puberty.
  • the current episode of 1 to 3 simultaneous RAS lesions must have started for less than 24 hours.

You may not qualify if:

  • \- patients who have any systemic disease or any extraoral lesions or manifestations.
  • receiving any systemic medications in general, receiving analgesic mouthwash or systemic analgesic before 24 hours of starting the study.
  • patients having allergy to sesame

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomatitis, Aphthous

Condition Hierarchy (Ancestors)

StomatitisMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 26, 2026

First Posted

October 1, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

October 1, 2026

Record last verified: 2026-09