NCT00070811

Brief Summary

The purpose of this study is to determine whether secondary (revision) surgery to the lip in patients with cleft lip and palate is effective in improving lip function and appearance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

August 1, 2001

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2003

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 13, 2003

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 4, 2013

Status Verified

July 1, 2013

Enrollment Period

11.3 years

First QC Date

October 8, 2003

Last Update Submit

July 2, 2013

Conditions

Cleft LipCleft Lip and Palate

Keywords

Facial formFacial animationLip muscle reconstructionLip formLip function

Outcome Measures

Primary Outcomes (1)

  • Facial movement/animation

    6

Secondary Outcomes (3)

  • Lip Force

    6

  • EMG

    6

  • Lip sensation

    6

Study Arms (3)

Revision

Patients with repaired cleft lip who receive lip revision surgery

Procedure: Lip revision surgery

Non-Revision

Patients with repaired cleft lip who do not have lip revision surgery

Non-cleft

Non-cleft 'control' subjects.

Interventions

Lip revision surgeryPROCEDURE

Full or partial muscle thickness lip revision surgery.

Also known as: Primary lip repair, Secondary lip repair
Revision

Eligibility Criteria

Age3 Months - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be recruited and screened mainly in the UNC Craniofacial Center, the Graduate Orthodontic Clinic, the Pediatric Dentistry Clinic, and the Orthodontic Faculty Practice of the University of North Carolina.

You may qualify if:

  • A previously-repaired complete unilateral or bilateral cleft lip and cleft palate;
  • For the lip revision patients, the professional clinical recommendation by the Center's craniofacial plastic surgeon for a full-thickness lip revision;
  • Patient interest / parent willingness to participate in the study;
  • An ability to comprehend verbal instructions; and
  • An age range of 5-17 yrs.

You may not qualify if:

  • The presence of an isolated cleft lip;
  • Previous lip-revision surgery or other facial soft-tissue surgery;
  • Previous orthognathic surgery;
  • A diagnosis of a craniofacial anomaly other than cleft lip and palate;
  • A medical history of diabetes, collagen vascular disease, systemic neurologic impairment; or
  • Mental or hearing impairment to the extent that comprehension or ability to perform the tests is hampered.
  • Non-cleft subjects.
  • Patient interest / parent willingness to participate in the study;
  • An ability to comprehend verbal instructions; and
  • An age range of 5-17 yrs.
  • Previous orthognathic or facial soft-tissue surgery;
  • A medical history of diabetes, collagen vascular disease, systemic neurologic impairment; or
  • Mental or hearing impairment to the extent that comprehension or ability to perform the tests is hampered.
  • Infants
  • Cleft lip and palate patients.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7450, United States

Location

Related Publications (25)

  • Andreatta RD, Barlow SM. Somatosensory gating is dependent on the rate of force recruitment in the human orofacial system. J Speech Lang Hear Res. 2009 Dec;52(6):1566-78. doi: 10.1044/1092-4388(2009/08-0116). Epub 2009 Aug 28.

    PMID: 19717653BACKGROUND

  • Trotman CA, Faraway JJ, Essick GK. Three-dimensional nasolabial displacement during movement in repaired cleft lip and palate patients. Plast Reconstr Surg. 2000 Apr;105(4):1273-83. doi: 10.1097/00006534-200004040-00003.

    PMID: 10744215BACKGROUND

  • Trotman CA, Faraway JJ, Silvester KT, Greenlee GM, Johnston LE Jr. Sensitivity of a method for the analysis of facial mobility. I. Vector of displacement. Cleft Palate Craniofac J. 1998 Mar;35(2):132-41. doi: 10.1597/1545-1569_1998_035_0132_soamft_2.3.co_2.

    PMID: 9527310BACKGROUND

  • Trotman CA, Faraway JJ. Sensitivity of a method for the analysis of facial mobility. II. Interlandmark separation. Cleft Palate Craniofac J. 1998 Mar;35(2):142-53. doi: 10.1597/1545-1569_1998_035_0142_soamft_2.3.co_2.

    PMID: 9527311BACKGROUND

  • Liu J, Xu HH, Zhou H, Weir MD, Chen Q, Trotman CA. Human umbilical cord stem cell encapsulation in novel macroporous and injectable fibrin for muscle tissue engineering. Acta Biomater. 2013 Jan;9(1):4688-97. doi: 10.1016/j.actbio.2012.08.009. Epub 2012 Aug 16.

    PMID: 22902812BACKGROUND

  • Liu J, Zhou H, Weir MD, Xu HH, Chen Q, Trotman CA. Fast-degradable microbeads encapsulating human umbilical cord stem cells in alginate for muscle tissue engineering. Tissue Eng Part A. 2012 Nov;18(21-22):2303-14. doi: 10.1089/ten.TEA.2011.0658. Epub 2012 Jul 19.

    PMID: 22697426BACKGROUND

  • Trotman CA, Phillips C, Essick GK, Faraway JJ, Barlow SM, Losken HW, van Aalst J, Rogers L. Functional outcomes of cleft lip surgery. Part I: Study design and surgeon ratings of lip disability and need for lip revision. Cleft Palate Craniofac J. 2007 Nov;44(6):598-606. doi: 10.1597/06-124.1.

    PMID: 18177192RESULT

  • Trotman CA, Faraway JJ, Losken HW, van Aalst JA. Functional outcomes of cleft lip surgery. Part II: Quantification of nasolabial movement. Cleft Palate Craniofac J. 2007 Nov;44(6):607-16. doi: 10.1597/06-125.1.

    PMID: 18177193RESULT

  • Essick GK, Phillips C, Trotman CA. Functional outcomes of cleft lip surgery. Part IV: Between- and within-participant variables affecting lip vermilion sensory thresholds. Cleft Palate Craniofac J. 2007 Nov;44(6):624-34. doi: 10.1597/06-129.1.

    PMID: 18177194RESULT

  • Trotman CA, Barlow SM, Faraway JJ. Functional outcomes of cleft lip surgery. Part III: Measurement of lip forces. Cleft Palate Craniofac J. 2007 Nov;44(6):617-23. doi: 10.1597/06-138.1.

    PMID: 18177195RESULT

  • Trotman CA, Faraway JJ, Phillips C. Visual and statistical modeling of facial movement in patients with cleft lip and palate. Cleft Palate Craniofac J. 2005 May;42(3):245-54. doi: 10.1597/04-010.1.

    PMID: 15865457RESULT

  • Essick GK, Dorion C, Rumley S, Rogers L, Young M, Trotman CA. Report of altered sensation in patients with cleft lip. Cleft Palate Craniofac J. 2005 Mar;42(2):178-84. doi: 10.1597/03-124.1.

    PMID: 15748109RESULT

  • Trotman CA, Phillips C, Faraway JJ, Ritter K. Association between subjective and objective measures of lip form and function: an exploratory analysis. Cleft Palate Craniofac J. 2003 May;40(3):241-8. doi: 10.1597/1545-1569_2003_040_0241_absaom_2.0.co_2.

    PMID: 12733951RESULT

  • Ritter K, Trotman CA, Phillips C. Validity of subjective evaluations for the assessment of lip scarring and impairment. Cleft Palate Craniofac J. 2002 Nov;39(6):587-96. doi: 10.1597/1545-1569_2002_039_0587_voseft_2.0.co_2.

    PMID: 12401105RESULT

  • Lee JY, Han Q, Trotman CA. Three-dimensional facial imaging: accuracy and considerations for clinical applications in orthodontics. Angle Orthod. 2004 Oct;74(5):587-93. doi: 10.1043/0003-3219(2004)0742.0.CO;2.

    PMID: 15529491RESULT

  • Faraway JJ, Trotman CA. Shape change along geodesics with application to cleft lip surgery. J R Stat Soc Ser C Appl Stat. 2011 Nov;60(5):743-755. doi: 10.1111/j.1467-9876.2011.01017.x. Epub 2011 Sep 29.

    PMID: 22639469RESULT

  • Trotman CA. Faces in 4 dimensions: Why do we care, and why the fourth dimension? Am J Orthod Dentofacial Orthop. 2011 Dec;140(6):895-9. doi: 10.1016/j.ajodo.2011.07.014.

    PMID: 22133956RESULT

  • Barlow SM, Trotman CA, Chu SY, Lee J. Modification of perioral stiffness in patients with repaired cleft lip and palate. Cleft Palate Craniofac J. 2012 Sep;49(5):524-9. doi: 10.1597/10-092. Epub 2011 Jan 19.

    PMID: 21247345RESULT

  • Tanikawa C, Takada K, van Aalst J, Trotman CA. Objective three-dimensional assessment of lip form in patients with repaired cleft lip. Cleft Palate Craniofac J. 2010 Nov;47(6):611-22. doi: 10.1597/09-099. Epub 2010 Mar 12.

    PMID: 20500076RESULT

  • Trotman CA, Faraway JJ, Phillips C, van Aalst J. Effects of lip revision surgery in cleft lip/palate patients. J Dent Res. 2010 Jul;89(7):728-32. doi: 10.1177/0022034510365485. Epub 2010 May 3.

    PMID: 20439935RESULT

  • Chu SY, Barlow SM, Lee J. Nonparticipatory stiffness in the male perioral complex. J Speech Lang Hear Res. 2009 Oct;52(5):1353-9. doi: 10.1044/1092-4388(2009/08-0101). Epub 2009 Aug 28.

    PMID: 19717655RESULT

  • Weismer G, Barlow S, Smith A, Caviness J. Special Panel Session: Driving Critical Initiatives in Motor Speech. J Med Speech Lang Pathol. 2008;16(4):283.

    PMID: 19421339RESULT

  • Chu SY, Barlow SM, Kieweg D, Lee J. OroSTIFF: Face-referenced measurement of perioral stiffness in health and disease. J Biomech. 2010 May 28;43(8):1476-82. doi: 10.1016/j.jbiomech.2010.01.037. Epub 2010 Feb 24.

    PMID: 20185131RESULT

  • Essick G, Phillips C, Chung Y, Trotman CA. Effects of lip revision surgery on long-term orosensory function in patients with cleft lip/palate. Cleft Palate Craniofac J. 2013 Sep;50(5):507-12. doi: 10.1597/11-247. Epub 2012 Aug 20.

    PMID: 22906391RESULT

  • Trotman CA, Faraway J, Soltmann R, Hartman T, van Aalst J. Facial soft tissue dynamics before and after primary lip repair. Cleft Palate Craniofac J. 2013 May;50(3):315-22. doi: 10.1597/12-080. Epub 2012 Oct 10.

    PMID: 23050657RESULT

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Carroll-Ann Trotman, BDS, MA, MS

    University of NC at Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor, Department of Orthodontics

Study Record Dates

First Submitted

October 8, 2003

First Posted

October 13, 2003

Study Start

August 1, 2001

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 4, 2013

Record last verified: 2013-07

Locations

US(1)