Evidence map›Paper›PMID 28667230›Full record

Trial reportBMJ open2017

Efficacy evaluation of an anti-caries varnish: protocol for a phase II randomised controlled trial.

Peter Milgrom, Ohnmar Tut, Marilynn Rothen, Lloyd Mancl, Marcelle Gallen, Jason M Tanzer

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03082196 (Phase 2 Efficacy Evaluation Of Advantage Anti-Caries Varnish), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT03082196 phase2completednot on this map

Phase 2 Efficacy Evaluation Of Advantage Anti-Caries Varnish

TypeinterventionalSponsorAdvantage Dental Services, LLCRan2017 to 2019Enrolled284ConditionsDental CariesArmsTest varnish, Standard varnish
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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.

Peter MilgromDepartment of Oral Health Sciences, School of Dentistry, University of Washington, Seattle, Washington, USA.ORCID 0000-0003-0784-9181
Ohnmar TutDepartment of Oral Health Sciences, School of Dentistry, University of Washington, Seattle, Washington, USA.
Marilynn RothenDepartment of Oral Health Sciences, School of Dentistry, University of Washington, Seattle, Washington, USA.
Lloyd ManclDepartment of Oral Health Sciences, School of Dentistry, University of Washington, Seattle, Washington, USA.
Marcelle GallenDepartment of Dental Services, Pohnpei State Health Department, Kolonia, Federated States of Micronesia.
Jason M TanzerDepartment of Oral and Maxillofacial Diagnostic Sciences, University of Connecticut Health Center, Farmington, Connecticut, USA.

Funding

Phase II RCT of Advantage Anti-Cavity VarnishR44DE022986 · NIDCR · ADP SILVER DENTAL ARREST, LLC · PI MILGROM, PETER M, SHIRTCLIFF, R MIKE · 2016 to 2016
$150k
NIDCR NIH HHS R44 DE022986
6 · The paper itself

Abstract

introductionDental caries (tooth decay) is a common disease in which the products of sugar metabolism by certain bacteria that populate the tooth surface induce the development and progression of lesions (cavities). This is a phase II single-centre randomised, double-blind, active-controlled, parallel-group trial to assess the efficacy of a combination povidone iodine and sodium fluoride dental varnish to determine if it is superior to a varnish containing only sodium fluoride in the prevention of new caries lesions. The objective of this report is to describe the rationale and protocol for the trial. METHODS AND ANALYSIS: The study site is Pohnpei State, Federated States of Micronesia. The study population is 284 children 48-84 months old. The primary outcome will be the surface-level primary molar caries increment (d ETHICS AND DISSEMINATION: The Western Institutional Review Board (designated IRB) and the Institutional Review Board of the College of Micronesia-FSM approved all study procedures. The US Food and Drug Administration (FDA) has issued IND 128835 covering this study. The study results will be published and submitted to the FDA in support of a new drug application. TRIALREGISTRATION NUMBER: NCT03082196.

Indexed as

Cariostatic AgentsChildChild, PreschoolDental CariesDrug CombinationsFemaleHumansMalePit and Fissure SealantsPovidone-IodineResearch DesignSodium FluorideTreatment OutcomeCariostatic AgentsDrug CombinationsPit and Fissure SealantsPovidone-IodineSodium FluorideDental Cariesfluoride varnishpovidone-iodine

Identifiers

PMID28667230
PMCPMC5663009

What OpenQuestion holds

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LicenceCC BY-NC
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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.