Evaluation of Topical Probiotic Gel Versus Triamcinolone in Minor Recurrent Aphthous Ulcers
22 juni 2026 uppdaterad 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
42
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Cairo, Egypten
- Faculty of Dentistry (Menoufia University and Modern University for Technology and Information (MTI), Egypt).
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
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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.
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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.
|
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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Minor Recurrent Aphthous Ulcer Size (mm) Measured Using Periodontal Probe
Tidsram: Baseline, 1 week, and 2 weeks after treatment initiation
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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.
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Baseline, 1 week, and 2 weeks after treatment initiation
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Pain Severity Measured Using Visual Analogue Scale (VAS 0-10)
Tidsram: Baseline, 1 week, and 2 weeks after treatment initiation
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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.
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Baseline, 1 week, and 2 weeks after treatment initiation
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Salivary microRNA-146a Expression Measured by qRT-PCR (ΔΔCt Method)
Tidsram: Baseline, 1 week and 2 weeks after treatment initiation
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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.
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Baseline, 1 week and 2 weeks after treatment initiation
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
20 februari 2026
Primärt slutförande (Faktisk)
20 april 2026
Avslutad studie (Faktisk)
20 april 2026
Studieregistreringsdatum
Först inskickad
17 juni 2026
Först inskickad som uppfyllde QC-kriterierna
22 juni 2026
Första postat (Faktisk)
29 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 juni 2026
Senast verifierad
1 februari 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- PROBIOTIC-ORAL-2026
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
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