Fluoride Concentration in Inter-proximal Fluid From Dental Sealants

Not Applicable

Completed

• Conditions: Caries
• Interventions: Other: sealant application

• Registration Number: NCT01588210
• Lead Sponsor: Università degli Studi di Sassari

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-03
• Study Completion: 2010-06
• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-04-30
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-17
• Last Update Posted: 2012-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2776

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glass Ionomer Cement group	sealant application	a high-viscosity glass-ionomer cement (KETAC™ MOLAR APLICAP 3M Espe, Germany)
Resin Based Fluoride Group	sealant application	white photopolymerizable Resin-Based sealant containing fluoride (Helioseal F®, Ivoclar Vivadent AG, Fürstentum Liechtenstein)
Resin Based sealant	sealant application	white photopolymerizable Resin-Based sealant (Concise 1930TM 3M Espe, Germany)

Primary Outcome Measures

Name	Time	Method
Inter-proximal fluid fluoride concentration	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 Outcome Measures

Name	Time	Method
caries incidence	24 months	measurement of tooth caries at D1, D2 D3 level (both enamel and dentinal caries)

Trial Locations

Locations (2)

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

WHO CC University of Milan; 🇮🇹 Milan, Italy