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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014