NCT01659463

Brief Summary

Material for caries prevention dont have better results compared with non-operatory interventions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

August 23, 2012

Status Verified

August 1, 2012

Enrollment Period

1.4 years

First QC Date

August 3, 2012

Last Update Submit

August 21, 2012

Conditions

Tooth; Lesion, White Spot Lesions

Keywords

CARIES INFILTRATIONCARIES LESIONINFILTRANT

Outcome Measures

Primary Outcomes (1)

  • caries progression in the proximal surfaces

    progression in the proximal surfaces will be compared with two procedures.

    One year after interventions

Study Arms (2)

ICON - low viscosity resin

EXPERIMENTAL

APPLICATION OF A LOW VISCOSITY RESIN IN EARLY PROXIMAL CARIES LESIONS

Other: ICON

INSTRUCTIONS ORAL HYGIENE

ACTIVE COMPARATOR

INSTRUCTION ORAL HYGIENE AND DIET AND TOOPICAL FLUORIDE APPLICATIONS

Behavioral: instruction oral hygiene

Interventions

ICONOTHER

LOW VISCOSITY RESIN WILL BE APPLIED IN EARLY PROXIMAL CARIES LESIONS

Also known as: ICON (DMG) Hamburg Germany
ICON - low viscosity resin
instruction oral hygieneBEHAVIORAL

Instructions diet and hygiene oral and topical fluoride

INSTRUCTIONS ORAL HYGIENE

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Two early caries lesion in the same patient, lesion with the same radiolucencies images

You may not qualify if:

  • Pregnancy, use of orthodontics appliences, use of drugs modified salivar flow, ausence of adjacent teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Santa Maria

Santa Maria, Rio Grande do Sul, 97105-900, Brazil

RECRUITING

Study Officials

  • Julio E Zenkner, MsC

    Universidade Federal de Santa Maria

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafaela Correia, student

CONTACT

+555599721234rafaela.tc@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MsC

Study Record Dates

First Submitted

August 3, 2012

First Posted

August 7, 2012

Study Start

April 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2013

Last Updated

August 23, 2012

Record last verified: 2012-08

Locations

BR(1)