Fluoride Concentration in Inter-proximal Fluid From Dental Sealants

Caries Clinical Trial

Official title:

Fluoride Concentration in Inter-proximal Fluid From Dental Sealants.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588210
• Other study ID #: 20120-01
• Secondary ID: 2011-10-11
• Status: Completed
• Phase: N/A
• First received: April 26, 2012
• Last updated: May 17, 2012
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: May 2012
• Source: Università degli Studi di Sassari
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2776
• Est. completion date: June 2010
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 7 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Caries

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Italy	WHO CC University of Milan	Milan
Italy	Department of Surgery, Microsurgery and Medicine Sciences University of Sassari	Sassari	Sardinia

Sponsors (2)

Lead Sponsor	Collaborator
Università degli Studi di Sassari	WHO Collaborating Centre for Epidemiology and Community Dentistry

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter-proximal fluid fluoride concentration	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.	21 days after application	No
Secondary	caries incidence	measurement of tooth caries at D1, D2 D3 level (both enamel and dentinal caries)	24 months	No