Efficacy of Glass-ionomer Fissure Sealants

• Conditions: Fissure Sealant; Glass-ionomer Cement; Permanent Molar

• Registration Number: NCT03235960
• Lead Sponsor: Association of Paediatric and Preventive Dentists of Serbia

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.

Study Timeline

• Study Start: 2004-01-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-31
• Last Update Submitted: 2017-07-31
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-01
• Study First Posted: 2017-08-01
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
absence of caries	every 12 months during 13 years	absence of caries on sealed tooth surfaces
retention of sealant	every 12 months during 13 years	complete or partial retention

Trial Locations

Locations (1)

University of Belgrade, School of Dental Medicine; 🇷🇸 Belgrade, Serbia