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

Fernanda Miori Pascon

Status and phase: Completed; Phase 1

Conditions: Dental Caries

Treatments: Other: Glass ionomer cement; Other: -Glass ionomer-; Other: Glass ionomer; Other: -Glass ionomer cement-

Study type: Interventional

Funder types: Other

Identifiers

NCT02659917

3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 147 patients

Sex: All

Ages: 5 to 9 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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147 participants in 4 patient groups

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

Active Comparator group

Description:

Pit and fissure sealing using conventional glass-ionomer cement

Treatment:

Other: Glass ionomer

Maxxion® (FGM) - Glass ionomer cement

Experimental group

Description:

Pit and fissure sealing using conventional glass-ionomer cement

Treatment:

Other: Glass ionomer cement

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

Active Comparator group

Description:

Restoration using conventional glass-ionomer cement

Treatment:

Other: -Glass ionomer-

Maxxion® (FGM) - Glass ionomer cement -

Experimental group

Description:

Restoration using conventional glass-ionomer cement

Treatment:

Other: -Glass ionomer cement-