Sequential PVP-I and FV
ConditionDental Caries
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-24
SponsorAdvantage Silver Dental Arrest, LLC
About this trial
This prospective cohort study in children will determine if: topical povidone iodine 10% followed by topical fluoride varnish is superior to placebo iodine followed two different varnishes alone to prevent tooth decay (dental caries).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children 6-24 months of age at enrollment. To be eligible a child will have at least 1 erupted tooth that is either sound or has only a d1 (white spot) lesion.
Disqualifiers
Previous treatment with fluoride varnish
Known allergy to iodine
Diagnosis of thyroid disease
Chronic, prophylactic use of antibiotics
Trial population
Children served by two health centers in Puno serving the "Control de Crecimiento y Desarrollo (CRED)" program and the Faculty of Health Sciences, Professional School of Dentistry, National University of the Altiplano, Puno, Peru.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
fluoride varnish, 2.5%
Devicesodium fluoride, 2.5%
topical fluoride, 2.1%
Devicesodium fluoride, 2.1%
Povidone Iodine Topical
DrugPovidone Iodine, 10%
Treatment groups
393 Participants
are divided into 3 treatment groupsGroup A: Povi+Fluorimax2 interventions
Group B: Placebo+Fluorimax1 intervention
Group C: Placebo+ClinPro1 intervention
Trial outcomes
Primary outcomes
1
Surface level caries
d2-4mfs
Time frame
24 monthsSecondary outcomes
1
Presence/Absence of dental caries lesions
d2-4mfs\>0
Time frame
24 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Advantage Silver Dental Arrest, LLC
Lead sponsor
Universidad Nacional del Altiplano de Puno
Collaborator
University of Washington
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: