Efficacy of Glass-ionomer Fissure Sealants

NCT ID: NCT03235960

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-01-01
• Study Completion Date: 2017-08-01

Brief Summary

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.

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.

Conditions

Fissure Sealant; Glass-ionomer Cement; Permanent Molar

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

glass-ionomer fissure sealant

The encapsulated glass-ionomer cement for fissure protection was applied onto the selected permanent molar according to the manufacturer's instruction

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Association of Paediatric and Preventive Dentists of Serbia

OTHER

Sponsor Role: lead

Responsible Party

Dejan Markovic

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dejan Markovic, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Belgrade, School of Dental Medicine

Locations

University of Belgrade, School of Dental Medicine

Belgrade, , Serbia

Countries

Serbia

Other Identifiers

001-04

Identifier Type: -

Identifier Source: org_study_id