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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Other: Glass ionomer; Other: Glass ionomer cement; Other: -Glass ionomer-; Other: -Glass ionomer cement-

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 Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ketac Molar® (3M/ESPE) - Glass ionomer; Pit and fissure sealing using conventional glass-ionomer cement	Other: Glass ionomer; Application of preventive agent
Experimental: Maxxion® (FGM) - Glass ionomer cement; Pit and fissure sealing using conventional glass-ionomer cement	Other: Glass ionomer cement; Application of preventive agent
Active Comparator: Ketac Molar® (3M/ESPE) - Glass ionomer -; Restoration using conventional glass-ionomer cement	Other: -Glass ionomer-; Atraumatic Restorative Treatment
Experimental: Maxxion® (FGM) - Glass ionomer cement -; Restoration using conventional glass-ionomer cement	Other: -Glass ionomer cement-; Atraumatic Restorative Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fernanda Miori Pascon
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: January 12, 2016
• First Submitted That Met QC Criteria: January 20, 2016
• First Posted (Estimate): January 21, 2016

Study Record Updates

• Last Update Posted (Estimate): January 21, 2016
• Last Update Submitted That Met QC Criteria: January 20, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: glass-ionomer cement; atraumatic restorative treatment; pit and fissure sealants
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No