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

NCT02659917 | Completed Phase 1 DMC

• 1 other identifier: 3
• Study Type: interventional
• Target: 147
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries

Keywords

glass-ionomer cement; atraumatic restorative treatment; pit and fissure sealants

Outcome Measures

Primary Outcomes (2)

• Number of the teeth with glass-ionomer cement retention and prevention of caries.

  Criteria established by Frencken et al. (1998) was used.

  6-month

• Number of the teeth with good restoration and caries absence.

  Criteria established by Frencken et al. (1998) was used.

  6-month

Secondary Outcomes (1)

• Frequency of loss of the sealing material and prevention of caries.

  6-month

Study Arms (4)

Ketac Molar® (3M/ESPE) - Glass ionomer

ACTIVE COMPARATOR

Pit and fissure sealing using conventional glass-ionomer cement

Other: Glass ionomer

Maxxion® (FGM) - Glass ionomer cement

EXPERIMENTAL

Pit and fissure sealing using conventional glass-ionomer cement

Other: Glass ionomer cement

Ketac Molar® (3M/ESPE) - Glass ionomer -

ACTIVE COMPARATOR

Restoration using conventional glass-ionomer cement

Other: -Glass ionomer-

Maxxion® (FGM) - Glass ionomer cement -

EXPERIMENTAL

Restoration using conventional glass-ionomer cement

Other: -Glass ionomer cement-

Interventions

-Glass ionomer- OTHER

Atraumatic Restorative Treatment

Ketac Molar® (3M/ESPE) - Glass ionomer -

-Glass ionomer cement- OTHER

Atraumatic Restorative Treatment

Maxxion® (FGM) - Glass ionomer cement -

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fernanda Miori Pascon: lead

MeSH Terms

Conditions

Dental Caries; Van der Woude syndrome

Interventions

glass ionomer; Glass Ionomer Cements

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Cements; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Teacher

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 21, 2016
• Study Start: August 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: August 1, 2010
• Last Updated: January 21, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share