Efficacy of Glass-ionomer Fissure Sealants

Clinical Efficacy of Glass-ionomer Fissure Sealants

Despite numerous techniques for enamel protection, occlusal caries still remains a problem. Sealing pits and fissures is considered to be an effective way of preventing caries development. Glass-ionomer cements are mainly recommended for pits and fissures sealing for two reasons. First, they are less susceptible to moisture which allows their use in noncooperable children or in partially erupted teeth where isolation could be a problem, and secondly, due to their potential to act as a fluoride reservoir making enamel more resistant to demineralisation. The purpose of the study is to clinically examine the caries-preventive effect of a glass-ionomer material for fissure protection in newly erupted permanent molars in children with low, moderate, and high caries-risk.

Study Overview

• Status: Unknown
• Conditions: Fissure Sealant; Glass-ionomer Cement; Permanent Molar
• Intervention / Treatment: Device: glass-ionomer fissure sealant

Detailed Description

Despite numerous techniques for enamel protection, such as topical fluorides, calcium phosphate-based remineralization systems, xylitol, etc., occlusal caries still remains a problem. A carious lesion occurs in pits and fissures of occlusal surfaces primarily due to their specific anatomy, which is considered to be an ideal site for the retention of bacteria and food remnants rendering mechanical means of debridement inaccessible. Sealing pits and fissures is considered to be an effective way of preventing caries development. Today, there is a wide spectrum of available sealing materials. Glass-ionomer cements are mainly recommended for pits and fissures sealing for two reasons. First, they are less susceptible to moisture which allows their use in noncooperable children or in partially erupted teeth where isolation could be a problem, and secondly, due to their potential to act as a fluoride reservoir making enamel more resistant to demineralisation. During last decades, glass-ionomer cements of different physical and chemical properties were used for pits and fissure sealing which probably contributed to variances in their clinical efficacy. The purpose of the study is to clinically examine the caries-preventive effect of a glass-ionomer material for fissure protection in newly erupted permanent molars in children with low, moderate, and high caries-risk.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia
    • University of Belgrade, School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 14 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy children who appeared for a regular dental examination

Description

Inclusion Criteria:

• at least one recently erupted permanent molar with sound pits and fissures
• healthy patients
• possibility to perform a dental treatment
• willing to participate in the study

Exclusion Criteria:

• teeth with an obvious cavity, with a restoration or a sealant completely or partially presented in the fissure system
• medically compromised patients
• non cooperative patients
• not willing to participate in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
absence of caries	absence of caries on sealed tooth surfaces	every 12 months during 13 years
retention of sealant	complete or partial retention	every 12 months during 13 years

Collaborators and Investigators

• Sponsor: Association of Paediatric and Preventive Dentists of Serbia
• Investigators: Principal Investigator: Dejan Markovic, PhD, University of Belgrade, School of Dental Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2004
• Primary Completion (ANTICIPATED): August 1, 2017
• Study Completion (ANTICIPATED): August 1, 2017

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (ACTUAL): August 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 001-04

Plan for Individual participant data (IPD)

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