Therapeutic Effect of Two Fluoride Varnishes on White Spot Lesions: a Clinical Study
1 other identifier
interventional
45
1 country
1
Brief Summary
The study hypothesis is the difference in therapeutic effect of two varnish formulations (G1 = NaF, 2.26%F, G2 = NaF, 2.71% F + CaF2). These products are commercially available in the Brazilian and international market and they are used for dental caries as white spot lesions control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2007
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 24, 2008
CompletedFirst Posted
Study publicly available on registry
July 28, 2008
CompletedJuly 28, 2008
July 1, 2008
4 months
July 24, 2008
July 24, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
reduction of the size of the caries lesion
4 weeks
Secondary Outcomes (1)
Inactivation of carious lesions
4 weeks
Study Arms (2)
G1
ACTIVE COMPARATORNaF (sodium fluoride varnish) with 2.26% of fluoride
G2
EXPERIMENTALNaF (sodium fluoride)2.71% of fluoride plus CaF2 (calcium fluoride)
Interventions
sodium fluoride 5%
sodium fluoride 5% + calcium fluoride
Eligibility Criteria
You may qualify if:
- regular hygiene habits (brushing teeth everyday)
- registered in public schools
You may not qualify if:
- dental caries such as small cavities or restorations in the target teeth (permanent anterior teeth)
- development enamel alterations (hypoplasia, fluorosis) or periodontal disease
- children using orthodontic devices
- under medical treatment
- taking any kind of medicine
- no informed consent form signed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pernambuco
Camaragibe, Pernambuco, 54753-220, Brazil
Related Publications (1)
Ferreira JM, Aragao AK, Rosa AD, Sampaio FC, Menezes VA. Therapeutic effect of two fluoride varnishes on white spot lesions: a randomized clinical trial. Braz Oral Res. 2009 Oct-Dec;23(4):446-51. doi: 10.1590/s1806-83242009000400015.
PMID: 20027453DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jainara MS Ferreira, Master
University of Pernambuco
- STUDY CHAIR
Ana Karla R Aragão, Graduate
Univeristy of Pernambuco
- STUDY CHAIR
Adriana DB Rosa, student
Federal University of Paraiba
- STUDY CHAIR
Fabio C Sampaio, PhD
Federal Univerisity of Paraiba
- STUDY CHAIR
Valdenice A Menezes, PhD
Univeristy of Pernambuco
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 24, 2008
First Posted
July 28, 2008
Study Start
February 1, 2007
Primary Completion
June 1, 2007
Study Completion
October 1, 2007
Last Updated
July 28, 2008
Record last verified: 2008-07