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Evaluation of Topical Probiotic Gel Versus Triamcinolone in Minor Recurrent Aphthous Ulcers

22. juni 2026 oppdatert av: Ahmed Adel Mohamed Abdelazim, Cairo University

Evaluation of Topical Probiotic Gel Versus Triamcinolone in Minor Recurrent Aphthous Ulcers: A Randomized Controlled Trial Incorporating Salivary microRNA-146a as a Novel Biomarker of Healing

This study looks at a new way to treat minor recurrent aphthous ulcers. These ulcers are painful, round or oval sores that show up on the soft, non-chewing surfaces of the mouth (like the inside of the cheeks or lips). While they are not dangerous, they cause severe pain and make eating, talking, and swallowing difficult.

The current standard treatment is usually a topical steroid gel called triamcinolone acetonide, which helps reduce pain and swelling but can have limitations. This clinical trial is testing whether a novel topical probiotic gel can work just as well as the steroid gel to speed up healing, lower pain, and reduce local inflammation.

Additionally, the study will measure a molecule found in saliva called microRNA-146a. This molecule acts as a natural biological marker that tracks how well the mouth tissue is healing from inflammation

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

42

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Egypt
      • Cairo, Egypt
        • Faculty of Dentistry (Menoufia University and Modern University for Technology and Information (MTI), Egypt).

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Both genders
  • Adults ≥18 years diagnosed with minor recurrent aphthous ulcer based on clinical examination (Parra-Moreno et al., 2023).
  • The definitive diagnostic criteria for Minor Recurrent Aphthous Ulcers (Minor RAU/RAS) rely heavily on distinct clinical features and standard medical histories. Because there is no single definitive lab test or histopathological standard, diagnosis is made primarily by clinical evaluation (Baccaglini et al., 2013; Akintoye and Greenberg, 2014)

Exclusion Criteria:

  • Patients with major aphthous ulcer or traumatic ulcers, patients took steroids in last 6 months, vulnerable groups as prisoners, mentally disabled, pregnant orlactating women (El-Haddad et al., 2014).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Group (1): Probiotic Gel Investigational Patient Group
A topical probiotic gel formulation designed for direct oral mucosal application. Participants will apply a thin layer of the experimental probiotic gel directly onto their minor recurrent aphthous ulcer lesion(s) four times daily. The therapeutic regimen will be maintained continuously for a duration of 1 to 2 weeks. Clinical assessments (lesion size; pain intensity via Visual Analogue Scale; and Thongprasom scoring) and salivary microRNA-146a biomarker collections will be systematically performed at baseline, 1 week, and 2 weeks.
Legemiddel: Probiotic gel
Topical probiotic gel formulation designed for oral mucosal application. Participants applied a thin layer of the probiotic gel directly onto the active minor aphthous ulcer lesion four times daily. The treatment was maintained for a duration of 1 to 2 weeks depending on individual healing timelines, with clinical assessments scheduled at baseline, 1 week, and 2 weeks.
Aktiv komparator: Group (2): Triamcinolone Active Control Patient Group
Active control topical corticosteroid paste/gel (Triamcinolone acetonide). Participants will apply a thin layer of the triamcinolone gel directly onto the active minor aphthous ulcer lesion four times daily. The treatment will be maintained for a duration of 1 to 2 weeks, matching the experimental arm timeline, with clinical and salivary biomarker assessments scheduled at baseline, 1 week, and 2 weeks.
Legemiddel: Triamcinelone acetonide
Active control topical corticosteroid paste/gel (Triamcinolone acetonide). Participants will apply a thin layer of the triamcinolone gel directly onto the active minor aphthous ulcer lesion four times daily. The treatment will be maintained for a duration of 1 to 2 weeks, matching the experimental arm timeline, with clinical and salivary biomarker assessments scheduled at baseline, 1 week, and 2 weeks.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Minor Recurrent Aphthous Ulcer Size (mm) Measured Using Periodontal Probe
Tidsramme: Baseline, 1 week, and 2 weeks after treatment initiation
The size of the target minor recurrent aphthous ulcer will be measured clinically in millimeters using a calibrated periodontal probe. The maximum ulcer diameter will be recorded at baseline, 1 week, and 2 weeks after treatment initiation. Change in ulcer size from baseline will be calculated. A reduction in size indicates clinical improvement and healing.
Baseline, 1 week, and 2 weeks after treatment initiation
Pain Severity Measured Using Visual Analogue Scale (VAS 0-10)
Tidsramme: Baseline, 1 week, and 2 weeks after treatment initiation
Pain severity related to the target aphthous ulcer will be assessed using a 0-10 Visual Analogue Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded at baseline, 1 week, and 2 weeks after treatment initiation. Change from baseline will be compared between the probiotic gel group and the triamcinolone group. A lower score indicates improvement.
Baseline, 1 week, and 2 weeks after treatment initiation

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Salivary microRNA-146a Expression Measured by qRT-PCR (ΔΔCt Method)
Tidsramme: Baseline, 1 week and 2 weeks after treatment initiation
Salivary microRNA-146a expression will be assessed from saliva samples using RNA extraction, reverse transcription, and real-time quantitative PCR. Relative expression will be calculated using the ΔCt and 2-ΔΔCt methods. Expression levels will be compared between baseline and post-treatment values to assess molecular changes related to inflammation and healing.
Baseline, 1 week and 2 weeks after treatment initiation

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cairo University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. februar 2026

Primær fullføring (Faktiske)

20. april 2026

Studiet fullført (Faktiske)

20. april 2026

Datoer for studieregistrering

Først innsendt

17. juni 2026

Først innsendt som oppfylte QC-kriteriene

22. juni 2026

Først lagt ut (Faktiske)

29. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. juni 2026

Sist bekreftet

1. februar 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • PROBIOTIC-ORAL-2026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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