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Completed

NCT Number: NCT01588210

Fluoride Concentration in Inter-proximal Fluid From Dental Sealants

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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Key information

Conditions

Caries

Age range

6 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Microsurgery and Medicine Sciences University of Sassari, Sassari, Sardinia, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sealant application

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.

Primary outcomes

  1. Inter-proximal fluid fluoride concentration

    Time frame: 21 days after application

    Inter-proximal fluid was collected with a paper point in the mesial inter-proximal space of the sealed tooth for 15 seconds. Each sample was prepared for the analysis as follow: added of 0.5 ml TISAB III to reach a pH 5 and shaken with magnetic stirrer thermostated at 25°C for 15 seconds. 100 ml of the solution was then placed on a Petri dish for the analysis. Fluoride concentration was carried out with an Orion model 96.09 fluoride ion selective electrode and an Orion model 900200 double junction plastic body Ag/AgCl reference electrode with an Orion model 290 mV digital meter.

Secondary outcomes

  1. caries incidence

    Time frame: 24 months

    measurement of tooth caries at D1, D2 D3 level (both enamel and dentinal caries)

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Sponsors and collaborators

Lead sponsor

Università degli Studi di Sassari

Other

Collaborators

  • World Health Organization

Registry information

Official study title

Fluoride Concentration in Inter-proximal Fluid From Dental Sealants.

Important dates

Study start
2008
Primary completion
2008
Study completion
2010
First posted
Apr 30, 2012
Registry last updated
May 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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