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

Tooth Demineralization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02400957
• Other study ID #: CEI-FE-023-013
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 24, 2015
• Last updated: March 26, 2015
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: March 2015
• Source: Universidad Autonoma de San Luis Potosí
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 35 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Tooth Demineralization

Intervention

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.
• 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.

Locations

Country	Name	City	State
Mexico	Gabriela Moreno Meraz	San Luis Potosi

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de San Luis Potosí

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

Hernández-Sierra JF, Galicia-Cruz O, Angélica SA, Ruiz F, Pierdant-Pérez M, Pozos-Guillén AJ. In vitro cytotoxicity of silver nanoparticles on human periodontal fibroblasts. J Clin Pediatr Dent. 2011 Fall;36(1):37-41. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	enamel demineralization (Diagnodent - pen evaluation)		8 weeks	Yes