Clinical trial NCT03082196: Efficacy Of A PVP-I Fluoride Varnish
Official title: Phase 2 Efficacy Evaluation Of Advantage Anti-Caries Varnish
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Caries
Keywords: sodium fluoride
povidone iodine
varnish
Lead sponsor: Advantage Dental Services, LLC
Sponsor class: INDUSTRY
First posted: 2017-03-17
Enrollment: 284
Sex: ALL
Minimum age (years): 60
Maximum age (years): 84
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, double-blind, controlled Phase 2 study with parallel groups of children.
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine the efficacy of Advantage Anti-Caries Varnish. Single-center, double-blind, controlled Phase 2 study with parallel groups of children. Subjects will be stratified by early childhood education center and then randomized to receive either test varnish or control varnish topically to the teeth. Treatment will be administered quarterly for up to 24 months. The primary outcome is surface-level primary molar caries increment (d2-4mfs) at 24- months post baseline.

Detailed description: Objectives:

Primary

- To determine if Advantage Anti-Caries Varnish (test varnish) is superior to a control varnish containing only fluoride in the prevention of new caries lesions.

Secondary

* To establish that the response of child participants to the test varnish was not inferior to the control varnish

Eligibility criteria: Inclusion Criteria:

1. The subject's parent or legal guardian must provide signed and dated informed consent (parent permission form).
2. The subject's parent or legal guardian of the subject must be willing and able to comply with study requirements.
3. The subject is aged 60-84 months at the time of enrollment.
4. The subject must be in good general health as evidenced by parent report.

Exclusion Criteria:

1. Known allergy to iodine
2. Known allergy to seafood
3. Known hypersensitivity to fluoride varnish
4. Diagnosis of thyroid disease
5. Chronic, prophylactic use of antibiotics
6. Treatment with another investigational drug or other intervention within 30 days preceding the Baseline Visit.

Primary outcomes:
measure: Dental Caries for Primary Molars Sound at Baseline
timeFrame: 24 months
measure: Dental Caries for All Primary Teeth Sound at Baseline
timeFrame: 24 months
Secondary outcomes:
measure: Child Response to First Treatment
timeFrame: After first treatment visit
measure: Child Response to Fifth Treatment
timeFrame: After fifth treatment visit
Other outcomes:
Locations:
city: Kolonia
country: Federated States of Micronesia
facility: Pohnpei State Hospital
Study officials:
affiliation: Advantage Silver Dental Arrest, LLC
name: Peter M Milgrom, DDS
role: STUDY_CHAIR
References:
citation: Milgrom P, Tut O, Rothen M, Mancl L, Gallen M, Tanzer JM. Addition of Povidone-Iodine to Fluoride Varnish for Dental Caries: A Randomized Clinical Trial. JDR Clin Trans Res. 2021 Apr;6(2):195-204. doi: 10.1177/2380084420922968. Epub 2020 May 21.
citation: Milgrom P, Tut O, Rothen M, Mancl L, Gallen M, Tanzer JM. Efficacy evaluation of an anti-caries varnish: protocol for a phase II randomised controlled trial. BMJ Open. 2017 Jun 30;7(6):e017866. doi: 10.1136/bmjopen-2017-017866.