Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets

March 26, 2015 updated by: Gabriela Moreno-Meraz, Universidad Autonoma de San Luis Potosí

Effectiveness of the Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets. ECCA

Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Randomized, split mouth, double-blind, placebo controlled trial. Half of the mouth was applied silver nanoparticles incorporated into the primer orthodontic Transbond XT and the other half with primer-bond as placebo. Evaluate the effectiveness with Diagnodent - pen in preventing enamel demineralization adjacent to brackets.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • San Luis Potosi, Mexico, 78210
        • Gabriela Moreno Meraz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients candidates for orthodontic treatment.

Exclusion Criteria:

  • Patients with O.D 11 and / or 21 absent.

    • Patients who present dentures of any kind in OD 11 and 21.
    • Patients presenting endodontic OD 11 and 21.
    • Patients presenting data gingivitis day cementing brackets.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Silver nanoparticles
Half of the mouth was applied silver nanoparticles. Allocation was randomized.
Other: Silver nanoparticles
Half of the mouth was applied silver nanoparticles. Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.
Experimental: Placebo
Half of the mouth was applied placebo. Allocation was randomized.
Other: Placebo
Half of the mouth was applied placebo. Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.
Other Names:
  • Primer-bond

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
enamel demineralization (Diagnodent - pen evaluation)
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de San Luis Potosí

Investigators

  • Study Director: Mauricio Pierdant, Profesor, Universidad Autonoma San Luis Potosi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Estimate)

March 27, 2015

Last Update Submitted That Met QC Criteria

March 26, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI-FE-023-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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