Therapeutic Effect of Two Fluoride Varnishes on White Spot Lesions: a Clinical Study
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ClinicalTrials.gov Identifier: NCT00723515 |
Recruitment Status
:
Completed
First Posted
: July 28, 2008
Last Update Posted
: July 28, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dental Caries | Drug: sodium fluoride Drug: sodium fluoride calcium fluoride | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Therapeutic Effect of Two Fluoride Varnishes on White Spot Lesions: a Clinical Study |
Study Start Date : | February 2007 |
Actual Primary Completion Date : | June 2007 |
Actual Study Completion Date : | October 2007 |
Arm | Intervention/treatment |
---|---|
Active Comparator: G1
NaF (sodium fluoride varnish) with 2.26% of fluoride
|
Drug: sodium fluoride
sodium fluoride 5%
Other Name: Duraphat®, Colgate Palmolive GmbH, Hamburg, Germany
|
Experimental: G2
NaF (sodium fluoride)2.71% of fluoride plus CaF2 (calcium fluoride)
|
Drug: sodium fluoride calcium fluoride
sodium fluoride 5% + calcium fluoride
Other Name: Duofluorid XII®, FGM, Joinville, Brazil
|
- reduction of the size of the caries lesion [ Time Frame: 4 weeks ]
- Inactivation of carious lesions [ Time Frame: 4 weeks ]

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Ages Eligible for Study: | 7 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- regular hygiene habits (brushing teeth everyday)
- registered in public schools
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723515
Brazil | |
University of Pernambuco | |
Camaragibe, Pernambuco, Brazil, 54753-220 |
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jainara Maria Soares Ferreira, University of Pernambuco |
ClinicalTrials.gov Identifier: | NCT00723515 History of Changes |
Other Study ID Numbers: |
UPE 260/08 |
First Posted: | July 28, 2008 Key Record Dates |
Last Update Posted: | July 28, 2008 |
Last Verified: | July 2008 |
Keywords provided by University of Pernambuco:
White spot lesion Tooth remineralization Fluoride varnishes |
Additional relevant MeSH terms:
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases Calcium, Dietary Fluorides Sodium Fluoride Fluorides, Topical |
Listerine Bone Density Conservation Agents Physiological Effects of Drugs Cariostatic Agents Protective Agents Anti-Infective Agents, Local Anti-Infective Agents |