Clinical Retention of Glass Ionomer Sealants Placed With and Without Rubber Dam: a Comparative Analysis

Dental Caries in Children Clinical Trial

Official title:

Clinical Retention of Glass Ionomer Sealants Placed With and Without Rubber Dam: a Comparative Analysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03989687
• Other study ID #: 19-138
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2019
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: Suzanne E Fournier, DDS
• Phone: 504-941-8199
• Email: sfour1[@]lsuhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A comparative analysis of glass ionomer sealant placed on permanent molars with and without a rubber dam to assess the retention over a 2 year period.

Description:

The purpose of the study is to compare the retention rates of glass ionomer sealants placed on first permanent molars over a period of 2 years. Pediatric patients (under <10 years of age) will receive a glass ionomer sealant on all four permanent first molars. One side will be randomly selected with rubber dam isolation and the contralateral side will have no rubber dam isolation for the placement of the sealant. Over a 2 year period, every 6 months the sealants will be assessed for retention.

The glass ionomer sealant material will be Fuji Triage (GC America). The following dental materials that will be used are cotton rolls, non-latex rubber dam, topical benzocaine, dental mirror, glass ionomer dispensing gun, dental explorer, triturator for the glass ionomer, cotton gauze, suction tip, air-water syringe.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

Inclusion Criteria: healthy children who need sealants on 4 permanent molars that are not hypo plastic, are caries-free, and with no enamel defects.

-

Exclusion Criteria: hypoplastic molars, caries, teeth with existing restorations, and those with enamel defects,

-

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Device:
• Fuji Triage
glass ionomer sealant

Other:
• isolation
rubber dam or cotton roll isolation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	retention rate of sealants	retention rate for sealants placed with different modes of isolation	6 months