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

Phase 1

Completed

• Conditions: Dental Caries
• Interventions: Other: Glass ionomer cement; Other: Glass ionomer; Other: -Glass ionomer cement-; Other: -Glass ionomer-

• Registration Number: NCT02659917
• Lead Sponsor: Fernanda Miori Pascon

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.

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 Timeline

• Study Start: 2008-08
• Primary Completion: 2009-02
• Study Completion: 2010-08
• Status Verified: 2016-01
• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-20
• Last Update Submitted: 2016-01-20
• Study First Posted: 2016-01-21
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maxxion® (FGM) - Glass ionomer cement	Glass ionomer cement	Pit and fissure sealing using conventional glass-ionomer cement
Ketac Molar® (3M/ESPE) - Glass ionomer	Glass ionomer	Pit and fissure sealing using conventional glass-ionomer cement
Maxxion® (FGM) - Glass ionomer cement -	-Glass ionomer cement-	Restoration using conventional glass-ionomer cement
Ketac Molar® (3M/ESPE) - Glass ionomer -	-Glass ionomer-	Restoration using conventional glass-ionomer cement

Primary Outcome Measures

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

Secondary Outcome Measures

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