NCT01588210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,776

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
Last Updated

May 18, 2012

Status Verified

May 1, 2012

Enrollment Period

2 months

First QC Date

April 26, 2012

Last Update Submit

May 17, 2012

Conditions

Caries

Keywords

cariessealantfluoridepreventioncommunity dentistry

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • caries incidence

    24 months

Study Arms (3)

Glass Ionomer Cement group

EXPERIMENTAL

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

Other: Sealant application

Resin Based Fluoride Group

EXPERIMENTAL

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

Other: sealant application

Resin Based sealant

PLACEBO COMPARATOR

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

Other: sealant application

Interventions

sealant applicationOTHER

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.

Glass Ionomer Cement group

Eligibility Criteria

Age6 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Surgery, Microsurgery and Medicine Sciences University of Sassari

Sassari, Sardinia, I-07100, Italy

Location

WHO CC University of Milan

Milan, I-20121, Italy

Location

Related Publications (2)

  • Cagetti MG, Carta G, Cocco F, Sale S, Congiu G, Mura A, Strohmenger L, Lingstrom P, Campus G; Italian Experimental Group on Oral Health. Effect of Fluoridated Sealants on Adjacent Tooth Surfaces: A 30-mo Randomized Clinical Trial. J Dent Res. 2014 Jul;93(7 Suppl):59S-65S. doi: 10.1177/0022034514535808. Epub 2014 May 20.

    PMID: 24846910DERIVED

  • Campus G, Carta G, Cagetti MG, Bossu M, Sale S, Cocco F, Conti G, Nardone M, Sanna G, Strohmenger L, Lingstrom P; Italian Experimental Group on Oral Health. Fluoride concentration from dental sealants: a randomized clinical trial. J Dent Res. 2013 Jul;92(7 Suppl):23S-8S. doi: 10.1177/0022034513484329. Epub 2013 May 20.

    PMID: 23690357DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Community Dentistry

Study Record Dates

First Submitted

April 26, 2012

First Posted

April 30, 2012

Study Start

January 1, 2008

Primary Completion

March 1, 2008

Study Completion

June 1, 2010

Last Updated

May 18, 2012

Record last verified: 2012-05

Locations

IT(2)