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Forehead Lift Fixation
This study has been completed.
Sponsored by: Federal University of Uberlandia
Information provided by: Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT00662961
  Purpose

To compare periosteum versus bone fixation in forehead lift.


Condition Intervention
Forehead
Procedure: Periosteum
Procedure: Bone

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Periosteum Versus Bone for the Fixation of Forehead Lift: A Prospective, Randomized, Controlled, Split-Face Trial.

Further study details as provided by Federal University of Uberlandia:

Primary Outcome Measures:
  • Eye brow position [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients' satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: January 2007
Study Completion Date: August 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Periosteum
Procedure: Periosteum
Periosteum fixation
2: Experimental
Bone
Procedure: Bone
Bone tunnel fixation

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eye brow malposition
  • Forehead wrinkles

Exclusion Criteria:

  • Previous surgery
  • Forehead trauma or scar
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662961

Locations
Brazil, mg
Federal University of Uberlandia, Department of ENT/H&N
Uberlandia, mg, Brazil, 38400-368
Sponsors and Collaborators
Federal University of Uberlandia
Investigators
Principal Investigator: Lucas G Patrocinio, MD Federal University of Uberlandia, Department of ENT/H&N
  More Information

Responsible Party: Federal University of Uberlandia ( Lucas G. Patrocinio )
Study ID Numbers: 2-Patrocinio
Study First Received: April 15, 2008
Last Updated: April 17, 2008
ClinicalTrials.gov Identifier: NCT00662961  
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Uberlandia:
Plastic Surgery

Study placed in the following topic categories:
Facies

ClinicalTrials.gov processed this record on January 16, 2009