NCT02400957

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

March 24, 2015

Last Update Submit

March 26, 2015

Conditions

Keywords

silver nanoparticlesdemineralizationbrackets

Outcome Measures

Primary Outcomes (1)

  • enamel demineralization (Diagnodent - pen evaluation)

    8 weeks

Study Arms (2)

Silver nanoparticles

EXPERIMENTAL

Half of the mouth was applied silver nanoparticles. Allocation was randomized.

Other: Silver nanoparticles

Placebo

EXPERIMENTAL

Half of the mouth was applied placebo. Allocation was randomized.

Other: Placebo

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.

Silver nanoparticles
PlaceboOTHER

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.

Also known as: Primer-bond
Placebo

Eligibility Criteria

Age10 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Location

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.

MeSH Terms

Conditions

Tooth Demineralization

Interventions

colloidal silver

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Mauricio Pierdant, Profesor

    Universidad Autonoma San Luis Potosi

    STUDY DIRECTOR

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

Locations