Performance of Glass-ionomer Cements: 2-year Follow-up

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ClinicalTrials.gov Identifier: NCT02659917

Recruitment Status : Completed

First Posted : January 21, 2016

Last Update Posted : January 21, 2016

Sponsor:

Information provided by (Responsible Party):

Fernanda Miori Pascon, University of Campinas, Brazil

Study Description

Brief Summary:

The purpose of this randomized clinical trial was evaluate the performance of two conventional glass-ionomer cements in the pit and fissure sealing and atraumatic restorative treatment in high caries risk children.

Condition or disease	Intervention/treatment	Phase
Dental Caries	Other: Glass ionomer Other: Glass ionomer cement Other: -Glass ionomer- Other: -Glass ionomer cement-	Phase 1

Detailed Description:

Sealants were applied on sound permanent first molars by "press finger technique" and carious deciduous molars that required either class I or class II restorations were restored according to manufacturers' recommendations in order to caries prevention and control.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	147 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Prevention
Official Title:	Performance of Glass-ionomer Cements in the Pit and Fissure Sealing and Atraumatic Restorative Treatment: a Randomized 2-year Clinical Trial
Study Start Date :	August 2008
Actual Primary Completion Date :	February 2009
Actual Study Completion Date :	August 2010

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MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Ketac Molar® (3M/ESPE) - Glass ionomer Pit and fissure sealing using conventional glass-ionomer cement	Other: Glass ionomer Application of preventive agent
Experimental: Maxxion® (FGM) - Glass ionomer cement Pit and fissure sealing using conventional glass-ionomer cement	Other: Glass ionomer cement Application of preventive agent
Active Comparator: Ketac Molar® (3M/ESPE) - Glass ionomer - Restoration using conventional glass-ionomer cement	Other: -Glass ionomer- Atraumatic Restorative Treatment
Experimental: Maxxion® (FGM) - Glass ionomer cement - Restoration using conventional glass-ionomer cement	Other: -Glass ionomer cement- Atraumatic Restorative Treatment

Outcome Measures

Primary Outcome Measures :

Number of the teeth with glass-ionomer cement retention and prevention of caries. [ Time Frame: 6-month ]
Criteria established by Frencken et al. (1998) was used.
Number of the teeth with good restoration and caries absence. [ Time Frame: 6-month ]
Criteria established by Frencken et al. (1998) was used.

Secondary Outcome Measures :

Frequency of loss of the sealing material and prevention of caries. [ Time Frame: 6-month ]
Criteria established by Frencken et al. (1998) was used.

Eligibility Criteria

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Ages Eligible for Study:	5 Years to 9 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Volunteers that having at least two permanent first molars of opposite sides of the mouth, erupted in the oral cavity, caries-free and high-risk disease (presence of white spots, history of caries, plaque in smooth surfaces and gingivitis);
Children who had one or two bilateral matched pairs of carious deciduous molars that required either class I or class II restorations.

Exclusion Criteria:

Children who did not meet the minimum requirements for the achievement of sealants or parents / guardians did not agree to participate;
No history of spontaneous pulpal pain.

Contacts and Locations

Information from the National Library of Medicine

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): NCT02659917

Sponsors and Collaborators

Fernanda Miori Pascon

Investigators

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Principal Investigator:	Raquel V Rodrigues, PhD Student	Piracicaba Dental School - University of Campinas
Principal Investigator:	Ana Carolina G Luciano, DDS	Piracicaba Dental School - University of Campinas
Principal Investigator:	Kelly MS Moreira, MS Student	Piracicaba Dental School - University of Campinas

More Information

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Responsible Party:	Fernanda Miori Pascon, Teacher, University of Campinas, Brazil
ClinicalTrials.gov Identifier:	NCT02659917
Other Study ID Numbers:	3
First Posted:	January 21, 2016 Key Record Dates
Last Update Posted:	January 21, 2016
Last Verified:	January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Fernanda Miori Pascon, University of Campinas, Brazil:


glass-ionomer cement atraumatic restorative treatment pit and fissure sealants

Additional relevant MeSH terms:

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Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases Methamphetamine Central Nervous System Stimulants Physiological Effects of Drugs Sympathomimetics Autonomic Agents	Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Dopamine Uptake Inhibitors

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