NCT05042843

Brief Summary

The aim of this study was to evaluate the effects of enamel deproteinization on the initial shear bond strength (SBS) and on the bracket/adhesive failure mode of orthodontic brackets bonded with a self-etching primer (SEP) as a primary objective. As secondary objective a Raman microscopy study was performed to assess the resin penetration into the enamel according to the three bonding protocols.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

8 months

First QC Date

September 1, 2021

Last Update Submit

September 6, 2021

Conditions

Orthodontic Appliance Complication

Keywords

glue penetrationorthodontic bracketsself-etching bracket

Outcome Measures

Primary Outcomes (1)

  • Number of resistance to tearing of orthodontic brackets stuck to extracted premolars

    Number of resistance to tearing of orthodontic brackets stuck to extracted premolars

    1 day

Eligibility Criteria

Age12 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patient with orthodontic treatment involving bicupids extractions

You may qualify if:

  • \- All patient with orthodontic treatment involving bicupids extractions

You may not qualify if:

  • \- Patients with damaged teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

NC

Study Officials

  • Stéphane BARTHELEMI, PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 13, 2021

Study Start

May 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 30, 2020

Last Updated

September 13, 2021

Record last verified: 2021-09

Locations

FR(1)