Evidence map›Paper›PMID 19137418›Full record

Trial reportPharmaceutical research2009

Distribution of anthocyanins delivered from a bioadhesive black raspberry gel following topical intraoral application in normal healthy volunteers.

Carlos M Ugalde, Zhongfa Liu, Chen Ren, Kenneth K Chan, Kapila A Rodrigo, Yhonghua Ling, Peter E Larsen, Guillermo E Chacon, Gary D Stoner, Russell J Mumper and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Pharmaceutical research, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01192204 (Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
1.7field-weighted citation impact, top 18% 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.

NCT01192204 phase1 / phase2completednot on this mapstarted 2010, after this paper: background citation

Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention

TypeinterventionalSponsorOhio State UniversityRan2010 to 2014Enrolled41ConditionsSquamous Cell Carcinoma of Mouth, Intraepithelial NeoplasiaArms10% FBR containing bioadhesive gel, placebo gel
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 40 citations in OpenAlex.

  1. Trial
  2. Article
  3. Oral Health and Nutraceutical Agents.International journal of molecular sciences · 2024
    Review
  4. Berries vs. Disease: Revenge of the Phytochemicals.Pharmaceuticals (Basel, Switzerland) · 2024
    Review
  5. Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
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  18. Article
  19. Article
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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

12 authors at 2 institutions in 1 country.

Carlos M UgaldeDivision of Oral Maxillofacial Surgery, Pathology & Anesthesiology, College of Dentistry, The Ohio State University, Columbus, Ohio, USA.
Zhongfa Liu
Chen Ren
Kenneth K Chan
Kapila A Rodrigo
Yhonghua Ling
Peter E Larsen
Guillermo E Chacon
Gary D Stoner
Russell J Mumper
Henry W Fields
Susan R Mallery
The Ohio State University · USUniversity of North Carolina at Chapel Hill · US

Funding

Chemoprevention of Head & Neck Cancer Using Controlled Release PolymersR01CA129609 · NCI · OHIO STATE UNIVERSITY · PI MALLERY, SUSAN R · 2009 to 2013
$1.5M
Evaluation of bioadhesive berry gels for oral cancer chemopreventionR21CA132138 · NCI · OHIO STATE UNIVERSITY · PI MALLERY, SUSAN R · 2008 to 2009
$390k
Formulation & Evaluation of Bioadhesive Gels for Oral Cancer ChemopreventionR41AT003342 · NCCIH · NANOMED PHARMACEUTICALS, INC. · PI MALLERY, SUSAN R · 2006 to 2006
$100k
NCCIH NIH HHS R41 AT003342NCI NIH HHS R01 CA129609NCI NIH HHS R21 CA132138
6 · The paper itself

Abstract

purposeResults from our oral cavity chemoprevention trial demonstrated appreciable interpatient variations regarding chemopreventive efficacy of a freeze dried black raspberry (FBR) gel. We speculated these data reflected individual patient-related differences in absorption, target tissue uptake and local compound metabolism of key FBR compounds (anthocyanins). Accordingly, this study assessed the distribution of anthocyanins from the 10% (w/w) FBR gel in saliva, oral tissues and plasma.

methodsHuman subject participation entailed collection of: (1) saliva, tissue and plasma (5 min following gel application, keratinized tissues), (2) saliva and plasma (5 min after sublingual gel application), (3) saliva and plasma at 1, 2, and 4 h post gel application (keratinized tissues), and (4) saliva (cyanidin 3-rutinoside incubations). Levels of FBR anthocyanins in the respective samples were analyzed by LC/MS/MS.

resultsOur data show: significantly higher anthocyanin levels in saliva and oral tissues relative to matched plasma samples, marked donor-specific variations in anthocyanin uptake, sustainability of anthocyanins at the target site, pH affects anthocyanin penetration and intraoral anthocyanin decomposition and/or metabolism.

conclusionsNo previous oral cavity chemoprevention trials evaluated compound distribution at the treatment site. Our data, which demonstrate a local delivery-derived pharmacologic advantage, provide insights which could advance oral cavity chemoprevention strategies.

Indexed as

RosaceaeAdhesivenessAdministration, OralAdministration, TopicalAdolescentAdultAnthocyaninsAnticarcinogenic AgentsBiotransformationChromatography, LiquidFemaleGelsHumansMaleMouthOral Surgical ProceduresAnthocyaninsAnticarcinogenic AgentsGelsPlant Preparations

Identifiers

PMID19137418
PMCPMC2678548
OpenAlexW2169592334

What OpenQuestion holds

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Read underepoch 390

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.