Trial reportBMC oral health2016
The safety and efficacy of AphtoFix® mouth ulcer cream in the management of recurrent aphthous stomatitis.
Trial report in BMC oral health, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed, 3 syntheses or guidelines pooled it, 14 citations in OpenAlex.
- Effectiveness of 0.1% triamcinolone acetonide compared with those of other therapies for minor recurrent aphthous stomatitis: a systematic review and meta-analysis of randomized controlled trials.BMC oral health · 2025Pooled it
- Topical Licorice for Aphthous: A Systematic Review of Clinical Trials.Iranian journal of medical sciences · 2023Pooled it
- Treatment of recurrent aphtous stomatitis: A systematic review.Medicina oral, patologia oral y cirugia bucal · 2023Pooled it
- Evolution of Drug Delivery Systems for Recurrent Aphthous Stomatitis.Drug design, development and therapy · 2021Review
- Large-Scale and Rapid Preparation of Nanofibrous Meshes and Their Application for Drug-Loaded Multilayer Mucoadhesive Patch Fabrication for Mouth Ulcer Treatment.ACS applied materials & interfaces · 2019Article
- Evaluation of Salivary Cortisol Changes and Psychological Profiles in Patients with Recurrent Aphthous Stomatitis.Contemporary clinical dentistryArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRecurrent Aphthous stomatitis (RAS) is a prevalent ulcerative and painful disorder of the oral cavity with unknown etiology and for which no efficient treatment is currently available. The present study aimed to evaluate the safety and the efficacy of AphtoFix®, a new mouth ulcer cream that was developed to help treat RAS. Prior to launching the product on the market, two initial safety assessment studies were performed. SUBJECTS AND
methodsIn a first study, the in vitro biocompatibility of AphtoFix® was evaluated on reconstructed human gingival tissue models according to ISO guidelines 10993. In a second study, the tolerability of AphtoFix® was evaluated in 20 subjects during a 4-weeks daily application in the mouth. The third study investigated both the safety and efficacy of AphtoFix® treatment on 19 patients suffering from RAS. This study was done in compliance with the Helsinki Declaration.
resultsThe results of in vitro biocompatibility study showed that AphtoFix® mouth ulcer cream did not induce any detectable cytotoxicity and irritation. These observations were confirmed in the 4 weeks tolerability study where no undesired of adverse reactions were noticed. The results of the post-market clinical efficacy study demonstrated a clear reduction in ulcer size from baseline after 3 days treatment (p < 0.05). Pain intensity reduction was also observed in all subjects.
conclusionThe application of AphtoFix® did not induce any undesired skin or mucosa reactions. These initial findings demonstrate that AphtoFix® is safe and efficient in reducing ulcer size and decreasing the pain intensity induced by ulcers.
trial registrationClinical trial Registry India Nr. CTRI201408004918 , Date of registration: 22/08/2014.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.