Forehead Lift Fixation

This study has been completed.
Sponsor:
Information provided by:
Federal University of Uberlandia
ClinicalTrials.gov Identifier:
NCT00662961
First received: April 15, 2008
Last updated: April 17, 2008
Last verified: April 2008
  Purpose

To compare periosteum versus bone fixation in forehead lift.


Condition Intervention
Forehead
Procedure: Periosteum
Procedure: Bone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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
Experimental: 1
Periosteum
Procedure: Periosteum
Periosteum fixation
Experimental: 2
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
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

No publications provided

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

Keywords provided by Federal University of Uberlandia:
Plastic Surgery

ClinicalTrials.gov processed this record on April 21, 2014