NCT00078507

Brief Summary

The purpose of this study is to determine whether facial exercises in conjunction with opening exercises routinely provided after facial surgery to correct a facial skeletal disharmony will shorten the time until a patient receives no unpleasant or negative facial sensation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2001

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

February 3, 2010

Status Verified

February 1, 2010

Enrollment Period

5.1 years

First QC Date

March 1, 2004

Last Update Submit

February 2, 2010

Conditions

Mandibular Advancement

Keywords

Outcome and Process Assessment (Health Care)Behavior ControlSensationRandomized Controlled TrialsAdolescentAdult

Outcome Measures

Primary Outcomes (5)

  • Perception of altered sensation

  • Perception of altered function

  • Two-point threshold

  • Two point discrimination

  • Contact detection

Study Arms (2)

Opening Exercises Only

ACTIVE COMPARATOR

Standard of care opening exercises following BSSO surgery to regain mouth opening

Behavioral: Opening Exercises

Sensory Retraining Exercises

EXPERIMENTAL

3 sets of facial exercises performed with soft cosmetic brush 1 wk - 4 wks after surgery; 4wks to 3 mos after surgery; 3 mos to 6 mos after surgery.

Behavioral: Sensory Re-trainingBehavioral: Sensory Retraining

Interventions

Sensory RetrainingBEHAVIORAL

Facial Exercises

Sensory Retraining Exercises
Opening ExercisesBEHAVIORAL
Opening Exercises Only

Eligibility Criteria

Age13 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Developmental dentofacial disharmony
  • Receives mandibular advancement by mandibular osteotomy with or without a maxillary procedure.

You may not qualify if:

  • Congenital anomaly or acute trauma affecting the face.
  • Previous facial surgery
  • Pregnant at baseline
  • Inability to follow written English instructions
  • Unwilling to sign informed consent.
  • No altered sensation at one week post-surgery
  • Altered sensation at baseline reported as numbness or unusual feeling.
  • Medical condition associated with systemic neuropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

University Oral and Maxillofacial Surgery

Charlotte, North Carolina, 28211, United States

Location

Study Officials

  • Ceib Phillips, DR

    Chapel Hill, School of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2004

First Posted

March 3, 2004

Study Start

December 1, 2001

Primary Completion

January 1, 2007

Study Completion

March 1, 2007

Last Updated

February 3, 2010

Record last verified: 2010-02

Locations

US(2)