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Completed

NCT Number: NCT02659917

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

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases Van der Woude syndrome

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glass ionomer

Other

Application of preventive agent

Glass ionomer cement

Other

Application of preventive agent

-Glass ionomer-

Other

Atraumatic Restorative Treatment

-Glass ionomer cement-

Other

Atraumatic Restorative Treatment

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Fernanda Miori Pascon

Other

Registry information

Official study title

Performance of Glass-ionomer Cements in the Pit and Fissure Sealing and Atraumatic Restorative Treatment: a Randomized 2-year Clinical Trial

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jan 21, 2016
Registry last updated
Jan 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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