Fluoride Concentration in Inter-proximal Fluid From Dental Sealants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2776 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Glass Ionomer Cement group

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

Group Type EXPERIMENTAL

Sealant application

Intervention Type OTHER

A high-viscosity glass-ionomer cement (KETAC™ MOLAR APLICAP 3M Espe, Germany) will be used.

All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam; tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary.

Resin Based Fluoride Group

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

Group Type EXPERIMENTAL

sealant application

Intervention Type OTHER

A white photopolymerizable Resin-Based sealant containing fluoride (Helioseal F®, Ivoclar Vivadent AG, Fürstentum Liechtenstein) will be used.

All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam (it was mandatory for both the RB sealants); tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary.

Resin Based sealant

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

Group Type PLACEBO_COMPARATOR

sealant application

Intervention Type OTHER

A white photopolymerizable Resin-Based sealant (Concise 1930TM 3M Espe, Germany) will be used.

All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam (it was mandatory for both the RB sealants); tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary.

Interventions

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Sealant application

A high-viscosity glass-ionomer cement (KETAC™ MOLAR APLICAP 3M Espe, Germany) will be used.

All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam; tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary.

Intervention Type OTHER

sealant application

A white photopolymerizable Resin-Based sealant containing fluoride (Helioseal F®, Ivoclar Vivadent AG, Fürstentum Liechtenstein) will be used.

All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam (it was mandatory for both the RB sealants); tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary.

Intervention Type OTHER

sealant application

A white photopolymerizable Resin-Based sealant (Concise 1930TM 3M Espe, Germany) will be used.

All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam (it was mandatory for both the RB sealants); tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No