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Dentistry and oral medicine
Protocol
Efficacy evaluation of an anti-caries varnish: protocol for a phase II randomised controlled trial
  1. Peter Milgrom1,2,
  2. Ohnmar Tut1,
  3. Marilynn Rothen1,3,
  4. Lloyd Mancl1,
  5. Marcelle Gallen4,
  6. Jason M Tanzer5
  1. 1 Department of Oral Health Sciences, School of Dentistry, University of Washington, Seattle, Washington, USA
  2. 2 Advantage Silver Dental Arrest, LLC, Redmond, Oregon, USA
  3. 3 Regional Clinical Dental Research Center, Institute of Translational Health Sciences, University of Washington, Seattle, Washington, USA
  4. 4 Department of Dental Services, Pohnpei State Health Department, Kolonia, Federated States of Micronesia
  5. 5 Department of Oral and Maxillofacial Diagnostic Sciences, University of Connecticut Health Center, Farmington, Connecticut, USA
  1. Correspondence to Dr. Peter Milgrom; dfrc{at}uw.edu

Abstract

Introduction Dental 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 (d2-3mfs/DMFS) at 2 years post baseline. The incremental dental caries at 1 year will also be compared between the two interventions. The secondary outcome is the Facial Image Scale after the initial treatment and after the fifth treatment at 1 year that gauges the child’s response to the treatment.

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.

  • Dental Caries
  • povidone-iodine
  • fluoride varnish

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-017866

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    Footnotes

    • Contributors PM, LM and JMT conceived of the study and wrote the original protocol. OT, MR and MG developed methods for recruitment and procedures and contributed to the revision of the protocol. All of the authors are part of the clinical trial implementation team. All of the others contributed to the final editing of the manuscript and agreed to its contents.

    • Funding This trial is funded by Advantage Silver Dental Arrest, 442 SW Umatilla, Suite 200, Redmond, OR 97756, USA. Planning funds were provided by a grant from the National Institute of Oral and Craniofacial Research, NIH (grant # 2R44 DE022986-02). PM is a director of Advantage Silver Dental Arrest. OT and JT are consultants to Advantage. Dr Tut is the principal investigator of the trial. The other authors declare no conflict of interest.

    • Competing interests PM is a director of Advantage Silver Dental Arrest, LLC. OT and JT are consultants to Advantage. Dr. Tut is the principal investigator of the trial. The other authors declare no conflict of interest.

    • Patient consent Obtained.

    • Ethics approval Western Institutional Review Board.

    • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

    • Data sharing statement The final dataset, including all forms, protocol and manual of procedures, will be maintained at the University of Washington and the offices of the sponsor. A copy will be filed with the US Food and Drug Administration. After filing, a public dataset will be available from the sponsor.