NCT02589743

Brief Summary

This study assessed long-term impact of tooth Eruption Stages (ES) on sealant retention on occlusal surfaces previously coated with intermediary bonding layer and it determined caries incidence outcome evolved. The treatment were (sealant/technique): Fluroshield; Helioseal Clear Chroma; Single Bond and Fluroshield; Excite and Helioseal Clear Chroma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2003

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
10.4 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

2 months

First QC Date

October 17, 2015

Last Update Submit

October 27, 2015

Conditions

Dental Caries

Keywords

clinical trialpit and fissure sealantstooth eruptionretentionadhesive systemintermediary layer

Outcome Measures

Primary Outcomes (1)

  • Sealant retention and prevention of dental caries assessed by defined clinical scoring system

    Clinical scoring system: adapted criteria proposed by Feigal et al. (2000)

    6-mouth

Study Arms (4)

Fluroshield - F (Sealant)

ACTIVE COMPARATOR

Pit and fissure sealing using only sealant

Device: Sealant

Single Bond and F (Adhesive and Sealant)

EXPERIMENTAL

Pit and fissure sealing using adhesive and sealant

Device: Adhesive and Sealant

Helioseal Clear Chroma - H (Sealant)

ACTIVE COMPARATOR

Pit and fissure sealing using only sealant

Device: Sealant

Excite and H (Adhesive and Sealant)

EXPERIMENTAL

Pit and fissure sealing using adhesive and sealant

Device: Adhesive and Sealant

Interventions

SealantDEVICE

Application of preventive agent

Fluroshield - F (Sealant)Helioseal Clear Chroma - H (Sealant)
Adhesive and SealantDEVICE

Application of preventive agent and technique for control moisture

Excite and H (Adhesive and Sealant)Single Bond and F (Adhesive and Sealant)

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Four caries-free erupted first molar permanent teeth; no systemic diseases and no dental material allergies.

You may not qualify if:

  • Carious or absence first molar permanent teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental CariesVan der Woude syndromeExanthema

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kamila Kantovitz, Phd

    Piracicaba Dental Scholl - University of Campinas

    PRINCIPAL INVESTIGATOR

  • Kelly Moreira, DDS

    Piracicaba Dental Scholl - University of Campinas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teacher

Study Record Dates

First Submitted

October 17, 2015

First Posted

October 28, 2015

Study Start

April 1, 2003

Primary Completion

June 1, 2003

Study Completion

June 1, 2005

Last Updated

October 28, 2015

Record last verified: 2015-10