Back to resultsAddition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets
Primary Purpose
Tooth Demineralization
Status
Unknown status
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Silver nanoparticles
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Tooth Demineralization focused on measuring silver nanoparticles, demineralization, brackets
Eligibility Criteria
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.
Sites / Locations
- Gabriela Moreno Meraz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Silver nanoparticles
Placebo
Arm Description
Half of the mouth was applied silver nanoparticles. Allocation was randomized.
Half of the mouth was applied placebo. Allocation was randomized.
Outcomes
Primary Outcome Measures
enamel demineralization (Diagnodent - pen evaluation)
Secondary Outcome Measures
Full Information
NCT ID
NCT02400957
First Posted
March 24, 2015
Last Updated
March 26, 2015
Sponsor
Universidad Autonoma de San Luis Potosí
1. Study Identification
Unique Protocol Identification Number
NCT02400957
Brief Title
Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets
Official Title
Effectiveness of the Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets. ECCA
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de San Luis Potosí
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Demineralization
Keywords
silver nanoparticles, demineralization, brackets
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Silver nanoparticles
Arm Type
Experimental
Arm Description
Half of the mouth was applied silver nanoparticles. Allocation was randomized.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Half of the mouth was applied placebo. Allocation was randomized.
Intervention Type
Other
Intervention Name(s)
Silver nanoparticles
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Primer-bond
Intervention Description
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.
Primary Outcome Measure Information:
Title
enamel demineralization (Diagnodent - pen evaluation)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauricio Pierdant, Profesor
Organizational Affiliation
Universidad Autonoma San Luis Potosi
Official's Role
Study Director
Facility Information:
Facility Name
Gabriela Moreno Meraz
City
San Luis Potosi
ZIP/Postal Code
78210
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
22900442
Citation
Hernandez-Sierra JF, Galicia-Cruz O, Angelica SA, Ruiz F, Pierdant-Perez M, Pozos-Guillen AJ. In vitro cytotoxicity of silver nanoparticles on human periodontal fibroblasts. J Clin Pediatr Dent. 2011 Fall;36(1):37-41. doi: 10.17796/jcpd.36.1.d677647166398886.
Results Reference
result
Learn more about this trial
Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets
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