Evidence map›Paper›PMID 35305150›Full record

ArticleClinical oral investigations2022

Safety and tolerability of cinnamaldehyde in orabase for oral candidiasis treatment: phase I clinical trial.

Danielle da Nóbrega Alves, Ana Karoline Vieira Melo, Adriano Francisco Alves, Maria Rejane Cruz de Araújo, Rubens da Silva Araújo, Ricardo Dias de Castro

Abstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Clinical oral investigations, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 41% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Review
  3. Antimicrobial efficacy of cinnamaldehyde combined with polymyxin B against carbapenem- polymyxin-resistant Klebsiella pneumoniae.Brazilian journal of microbiology : [publication of the Brazilian Society for Microbiology] · 2025
    Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Danielle da Nóbrega AlvesDepartment of Clinical and Social Dentistry, Graduate Program in Natural and Synthetic Bioactive Products (PgPNSB), Health Sciences Center, Federal University of Paraiba, João Pessoa, PB, Brazil.ORCID http://orcid.org/0000-0002-3072-0928
Ana Karoline Vieira MeloDepartment of Clinical and Social Dentistry, Federal University of Paraiba, João Pessoa, Brazil.ORCID http://orcid.org/0000-0001-8900-7193
Adriano Francisco AlvesDepartment of Physiology and Pathology, Health Sciences Center, Federal University of Paraiba, João Pessoa, PB, Brazil.ORCID http://orcid.org/0000-0003-2038-1894
Maria Rejane Cruz de AraújoDepartment of Clinical and Social Dentistry, Federal University of Paraiba, João Pessoa, Brazil.ORCID http://orcid.org/0000-0003-3599-4781
Rubens da Silva AraújoHealth Sciences Center, Federal University of Paraiba, João Pessoa, PB, Brazil.ORCID http://orcid.org/0000-0002-9445-4761
Ricardo Dias de CastroDepartment of Clinic and Social Dentistry, Health Sciences Center, Federal University of Paraiba, Campus I, João Pessoa, PB, 58051-970, Brazil. rcastro@ccs.ufpb.br.ORCID http://orcid.org/0000-0001-7986-7376
Universidade Federal da Paraíba · BR

Funding

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior PROEX AUXPE - 0521/2020
6 · The paper itself

Abstract

objectiveTo advance studies on the effect of a new pharmaceutical formulation for the treatment of oral fungal infections, we evaluated the safety and tolerability of orabase ointment containing cinnamaldehyde for use on the oral mucosa. MATERIAL AND

methodsA clinical trial (phase I) was carried out on 35 individuals with healthy oral mucosa divided into three groups: ointments at 200 µg/mL, n = 12; 300 µg/mL, n = 11; and 400 µg/mL, n = 12. Product safety was assessed using three parameters: (a) clinical evolution as recorded by trained examiners; (b) evolution of the inflammatory process as registered by an exfoliative cytology exam and analyzed by trained pathologists; (c) mucosal swab to count Candida spp. colony-forming units (CFU). These parameters were analyzed both beforehand and at 15 days of treatment.

resultsThe three ointment concentrations evaluated did not trigger inflammatory processes. The mycological analyses revealed a reduction of at least 99% in the number of Candida spp. CFU. In the exfoliative cytology analyses, the cells were found to be healthy. Participants reported a pleasant taste, yet 17% reported a slight burning sensation when applying the product.

conclusionsThe ointment is safe and tolerable for use on healthy oral mucosa.

trial registrationRegistration number: RBR-7zwzs3. CLINICAL RELEVANCE: The ointment proved to be safe and tolerable for use on oral mucosa, encouraging studies to evaluate its clinical efficacy in patients with oral candidiasis, and contributing to a new therapeutic proposal for the treatment of fungal infections caused by Candida spp.

Indexed as

Candidiasis, OralMycosesAcroleinAntifungal AgentsCandidaCarboxymethylcellulose SodiumHumansOintmentsAcroleinAntifungal AgentsCarboxymethylcellulose SodiumcinnamaldehydeOintmentsOrabaseAntifungalAntimicrobial productsBiological productsOral candidiasis

Identifiers

PMID35305150
OpenAlexW4220656339

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.