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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01538524
Other study ID # 201109008RB
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 20, 2012
Last updated February 23, 2012
Start date February 2012
Est. completion date February 2014

Study information

Verified date January 2012
Source National Taiwan University Hospital
Contact Pi-Huei Liu
Phone 886-23562347
Email 017468@ntuh.gov.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date February 2014
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Patient who only had partial orthodontic treatment

- Pregnancy

Study Design

Observational Model: Case-Only


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital
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