Fluoride Concentration in Inter-proximal Fluid From Dental Sealants

This study has been completed.
Sponsor:
Collaborator:
WHO Collaborating Centre for Epidemiology and Community Dentistry
Information provided by (Responsible Party):
Guglielmo Campus, Università degli Studi di Sassari
ClinicalTrials.gov Identifier:
NCT01588210
First received: April 26, 2012
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Caries
Other: Sealant application
Other: sealant application

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fluoride Concentration in Inter-proximal Fluid From Dental Sealants.

Resource links provided by NLM:


Further study details as provided by Università degli Studi di Sassari:

Primary Outcome Measures:
  • Inter-proximal fluid fluoride concentration [ Time Frame: 21 days after application ] [ Designated as safety issue: No ]
    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:
  • caries incidence [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    measurement of tooth caries at D1, D2 D3 level (both enamel and dentinal caries)


Enrollment: 2776
Study Start Date: January 2008
Study Completion Date: June 2010
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glass Ionomer Cement group
a high-viscosity glass-ionomer cement (KETAC™ MOLAR APLICAP 3M Espe, Germany)
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.

Experimental: Resin Based Fluoride Group
white photopolymerizable Resin-Based sealant containing fluoride (Helioseal F®, Ivoclar Vivadent AG, Fürstentum Liechtenstein)
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.

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


  Eligibility

Ages Eligible for Study:   6 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588210

Locations
Italy
Department of Surgery, Microsurgery and Medicine Sciences University of Sassari
Sassari, Sardinia, Italy, I-07100
WHO CC University of Milan
Milan, Italy, I-20121
Sponsors and Collaborators
Università degli Studi di Sassari
WHO Collaborating Centre for Epidemiology and Community Dentistry
  More Information

No publications provided by Università degli Studi di Sassari

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guglielmo Campus, Associate professor of Community Dentistry, Università degli Studi di Sassari
ClinicalTrials.gov Identifier: NCT01588210     History of Changes
Other Study ID Numbers: 20120-01, 2011-10-11
Study First Received: April 26, 2012
Last Updated: May 17, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Università degli Studi di Sassari:
caries
sealant
fluoride
prevention
community dentistry

Additional relevant MeSH terms:
Fluorides
Cariostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 23, 2014