Resin Infiltratration on the Sealing of Proximal Early Caries

Tooth; Lesion, White Spot Lesions Clinical Trial

Official title:

Resin Infiltration on Teh Sealing of Proximal Early Caries Lesins: a Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01659463
• Other study ID #: 0347.0243.000-10
• Status: Recruiting
• Phase: N/A
• First received: August 3, 2012
• Last updated: August 21, 2012
• Start date: April 2011
• Est. completion date: September 2013

Study information

• Verified date: August 2012
• Source: Universidade Federal de Santa Maria
• Contact: Rafaela Correia, student
• Phone: +555599721234
• Email: rafaela.tc[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

Two gruops will be compared. One using ICON and another gruop with non-operatory interventions consisted in hygiene instrutions and fluoride topical application. The caries progression will be evalueted with radiographic observation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tooth; Lesion, White Spot Lesions

Intervention

Other:
• ICON
LOW VISCOSITY RESIN WILL BE APPLIED IN EARLY PROXIMAL CARIES LESIONS

Behavioral:
• instruction oral hygiene
Instructions diet and hygiene oral and topical fluoride

Locations

Country	Name	City	State
Brazil	Federal University of Santa Maria	Santa Maria	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Maria

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	caries progression in the proximal surfaces	progression in the proximal surfaces will be compared with two procedures.	One year after interventions	No