NCT01538524

Brief Summary

Patient safety is a great concern for the whole society. Since the investigators have a leadership in the medical field in Taiwan, the investigators should be courageous to face the reality from the patients seeking second opinions undergoing orthodontic treatment. Orthodontics just became a recognized specialty by the Department of Health in Taiwan in 2009. It is just a beginning to set up the training course criteria at the national level. It will be a good timing for us to look at the treatment quality when patients seeking second opinions at NTUH. Whether the unsatisfied results are from the patient's unrealistic expectation, patient's compliance issue, doctor's diagnosis, treatment planning or skills, or a simple communication problem, depend on a good systemic analysis from the records and questionnaire collected in a timely fashion. The investigators plan to ask patients who are undergoing full-mouth orthodontic treatment and seeking second opinion to join this study. The investigators will thoroughly explain to patients before they agree to take records and fill in questionnaire. Then the investigators use these records to perform root cause analysis. Our hypothesis is that the risk of adverse event (AE) is related to the training quality, communication skills, patient's understanding and compliance. From these results, the investigators shall be able to assess the risk of AE and make the education policy either at continued education level or special training courses towards a patient satisfied treatment.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2012

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

February 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 24, 2012

Status Verified

January 1, 2012

First QC Date

February 20, 2012

Last Update Submit

February 23, 2012

Conditions

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who are not under full mouth fixed orthodontic treatment in National Taiwan University Hospital

You may qualify if:

  • Patients who are not under full mouth fixed orthodontic treatment in National Taiwan University Hospital

You may not qualify if:

  • Patient who only had partial orthodontic treatment
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Pi-Huei Liu

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2012

First Posted

February 24, 2012

Study Start

February 1, 2012

Study Completion

February 1, 2014

Last Updated

February 24, 2012

Record last verified: 2012-01