Evidence map›Paper›PMID 30575794›Full record

Trial reportScientific reports2018

Propolis-based niosomes as oromuco-adhesive films: A randomized clinical trial of a therapeutic drug delivery platform for the treatment of oral recurrent aphthous ulcers.

Mona G Arafa, Dalia Ghalwash, Dina M El-Kersh, M M Elmazar

Erratum issuedOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Scientific reports, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 49 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 2 pooled it
7.7field-weighted citation impact, top 2% 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

49 citing papers in PubMed, 2 syntheses or guidelines pooled it, 116 citations in OpenAlex.

  1. Pooled it
  2. Treatment of recurrent aphtous stomatitis: A systematic review.Medicina oral, patologia oral y cirugia bucal · 2023
    Pooled it
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  17. Influence of Thermal Treatment on the Composition ofInternational journal of molecular sciences · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

Mona G ArafaDepartment of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, The British University in Egypt (BUE), El-Sherouk city, Cairo, 11837, Egypt. mona.arafa@bue.edu.eg.
Dalia GhalwashDepartment of Oral Medicine and Periodontology, Faculty of dentistry, The British University in Egypt (BUE), El-Sherouk city, Cairo, 11837, Egypt.
Dina M El-KershDepartment of Pharmacognosy, Faculty of Pharmacy, The British University in Egypt (BUE), El-Sherouk city, Cairo, 11837, Egypt.
M M ElmazarDepartment of Pharmacology, Faculty of Pharmacy, The British University in Egypt (BUE), El-Sherouk city, Cairo, 11837, Egypt.
British University in Egypt · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Oromuco-adhesive films for buccal delivery of Propolis extract (PPE) entrapped in niosomes, were prepared to treat oral recurrent aphthous ulcer (RAU). PPE was investigated for antimicrobial compounds. Niosomes composed of span60 and cholesterol were evaluated for particles size, polydispersity index (PDI), zeta-potential, entrapment efficiency and in vitro release. The formed oromuco-adhesive films containing niosomal PPE were evaluated for swelling, mucoadhesion and elasticity. 24 patients suffering from RAU were divided equally into medicated and placebo groups and participated in this study to examine the onset of ulcer size reduction, complete healing and pain relief. Ultra-performance liquid chromatography-high resolution mass spectrometry revealed the presence of pinocembrin, pinobanksin, chrysin and galangin as antimicrobial flavonoids with total content of 158.7 ± 0.15 µg quercetin equivalents and phenolic content of 180.8 ± 0.11 µg gallic acid equivalents/mg. Multilamellar niosomes of 176-333 nm displayed entrapment efficiency of 91 ± 0.48%, PDI of 0.676 and zeta potential of -4.99. In vitro release after 8 h from niosomal dispersion and films were 64.05% and 29.09 ± 0.13% respectively. Clinical results revealed duration of film adherence from 2-4 h in the two groups. The onset of ulcer size reduction in medicated group was attained within second and third day, complete healing was achieved within first 10 days of treatment and pain relief lasted for more than 4-5 h, in contrast to the placebo group. This oromuco-adhesive films which offer controlled and targeting drug delivery can be proposed as a new therapeutic strategy in the treatment of oral recurrent aphthous ulcer.

Indexed as

AdhesivesAdministration, OralAdolescentAdultAnimalsApitherapyCell Membrane PermeabilityChickensDrug Delivery SystemsFemaleHumansLiposomesMaleMembranes, ArtificialModels, BiologicalMouth MucosaAdhesivesLiposomesMembranes, ArtificialPropolis

Identifiers

PMID30575794
PMCPMC6303391
OpenAlexW2905420437

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.