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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00662961
Other study ID # 2-Patrocinio
Secondary ID
Status Completed
Phase N/A
First received April 15, 2008
Last updated April 17, 2008
Start date January 2007
Est. completion date August 2007

Study information

Verified date April 2008
Source Federal University of Uberlandia
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

To compare periosteum versus bone fixation in forehead lift.


Description:

Forehead lift method of fixation is variable and lots of different methods have been described with different rates of success.

The comparison of to different techniques in a RCT has not been reported before.

The objective is to compare periosteum versus bone fixation in forehead lift, in a randomized, blinded, controlled, split-face trial.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date August 2007
Est. primary completion date July 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 70 Years
Eligibility Inclusion Criteria:

- Eye brow malposition

- Forehead wrinkles

Exclusion Criteria:

- Previous surgery

- Forehead trauma or scar

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Periosteum
Periosteum fixation
Bone
Bone tunnel fixation

Locations

Country Name City State
Brazil Federal University of Uberlandia, Department of ENT/H&N Uberlandia MG

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Eye brow position 6 months No
Secondary Patients' satisfaction 6 months No
Secondary Complications 6 months Yes