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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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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




Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. Frequency of loss of the sealing material and prevention of caries. [ Time Frame: 6-month ]
    Criteria established by Frencken et al. (1998) was used.



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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.

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
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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