Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets
Effectiveness of the Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets. ECCA
1 other identifier
interventional
40
1 country
1
Brief Summary
Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2014
Shorter than P25 for phase_3
1 active site
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
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 24, 2015
CompletedFirst Posted
Study publicly available on registry
March 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMarch 27, 2015
March 1, 2015
8 months
March 24, 2015
March 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
enamel demineralization (Diagnodent - pen evaluation)
8 weeks
Study Arms (2)
Silver nanoparticles
EXPERIMENTALHalf of the mouth was applied silver nanoparticles. Allocation was randomized.
Placebo
EXPERIMENTALHalf of the mouth was applied placebo. Allocation was randomized.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients candidates for orthodontic treatment.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gabriela Moreno Meraz
San Luis Potosí City, San Luis Potosí, 78210, Mexico
Related Publications (1)
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.
PMID: 22900442RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mauricio Pierdant, Profesor
Universidad Autonoma San Luis Potosi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MsC
Study Record Dates
First Submitted
March 24, 2015
First Posted
March 27, 2015
Study Start
September 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
March 27, 2015
Record last verified: 2015-03