Fluoride Concentration in Inter-proximal Fluid From Dental Sealants

Università degli Studi di Sassari

Status: Completed

Conditions: Caries

Treatments: Other: sealant application; Other: Sealant application

Study type: Interventional

Funder types: Other

Identifiers

NCT01588210

2011-10-11 (Registry Identifier)

20120-01

Details and patient eligibility

About

The hypothesis of this study is that the concentration of fluoride in oral interproximal fluids would increase more after using high-viscosity GIC as pit and fissure sealant, compared to Resin-Based sealants containing fluoride and RB sealants without fluoride content. To validate this hypothesis a randomized clinical trial was designed and performed in schoolchildren in order to evaluate fluoride release in inter-proximal fluid in vivo after the placement of three types of sealants: high-viscosity GIC, Resin-Based sealants containing fluoride and RB sealants without fluoride content.

Enrollment: 2,776 patients

Sex: All

Ages: 6 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The inclusion criteria are: year of birth between 2000 and 2002, informed consent signed by parents/guardians, presence of at least two permanent first molars completely erupted.

Exclusion criteria

• The exclusion criteria are: demineralized lesions and hypomineralized permanent molar, carious lesions or presence of filling on the occlusal surface of the first permanent molar, fixed orthodontic treatment.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,776 participants in 3 patient groups, including a placebo group

Glass Ionomer Cement group

Experimental group

Description:

a high-viscosity glass-ionomer cement (KETAC™ MOLAR APLICAP 3M Espe, Germany)

Treatment:

Other: Sealant application

Resin Based Fluoride Group

Experimental group

Description:

white photopolymerizable Resin-Based sealant containing fluoride (Helioseal F®, Ivoclar Vivadent AG, Fürstentum Liechtenstein)

Treatment:

Other: sealant application

Other: sealant application

Resin Based sealant

Placebo Comparator group

Description:

white photopolymerizable Resin-Based sealant (Concise 1930TM 3M Espe, Germany)

Treatment:

Other: sealant application

Other: sealant application