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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02659917
• Other study ID #: 3
• Status: Completed
• Phase: Phase 1
• First received: January 12, 2016
• Last updated: January 20, 2016
• Start date: August 2008
• Est. completion date: August 2010

Study information

• Verified date: January 2016
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: August 2010
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 9 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Glass ionomer
Application of preventive agent
• Glass ionomer cement
Application of preventive agent
• -Glass ionomer-
Atraumatic Restorative Treatment
• -Glass ionomer cement-
Atraumatic Restorative Treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fernanda Miori Pascon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of the teeth with glass-ionomer cement retention and prevention of caries.	Criteria established by Frencken et al. (1998) was used.	6-month	Yes
Primary	Number of the teeth with good restoration and caries absence.	Criteria established by Frencken et al. (1998) was used.	6-month	Yes
Secondary	Frequency of loss of the sealing material and prevention of caries.	Criteria established by Frencken et al. (1998) was used.	6-month	Yes