Efficacy of Glass-ionomer Fissure Sealants

NCT03235960 | Unknown DMC

• 1 other identifier: 001-04
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Fissure Sealant; Glass-ionomer Cement; Permanent Molar

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

glass-ionomer fissure sealant DEVICE

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

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy children who appeared for a regular dental examination

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association of Paediatric and Preventive Dentists of Serbia: lead

Study Sites (1)

University of Belgrade, School of Dental Medicine

Belgrade, Serbia

Location

Study Officials

• Dejan Markovic, PhD

  University of Belgrade, School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: August 1, 2017
• Study Start: January 1, 2004
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)