Assessing the Results of Lip Surgery in Patients With Cleft Lip and Palate
NCT ID: NCT00070811
Last Updated: 2013-07-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
127 participants
Study Classification
OBSERVATIONAL
Study Start Date
2001-08-31
Study Completion Date
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Articulation and Phonology in Children With Unilateral Cleft Lip and Palate
NCT00829101
Cleft Palate
Cleft Lip
COMPLETED
Primary Palatoplasty in Pediatric Patients - A Retrospective Review of Surgical Outcomes
NCT01380171
Cleft Lip
Cleft Palate
COMPLETED
Improving Informed Consent for Cleft Palate Repair
NCT02595307
Cleft Palate
Jaw Abnormalities
Maxillofacial Abnormalities
+8 more
UNKNOWN
NA
Early Intervention in Infants With Unrepaired Cleft Palate: Language, Palatal Function, and Articulation.
NCT07219901
Cleft Lip and Cleft Palate
Cleft Lip Palate
Cleft Lip and/or Palate
+4 more
NOT_YET_RECRUITING
NA
Improving Outcomes in Cleft Palate Surgery
NCT02583100
Cleft Palate
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Children born with clefting of the upper lip exhibit obvious disfigurement of the upper lip and nose. As illustrated below, primary lip surgery of the infant dramatically improves the severe deformity of the perioral and nasal region. It is widely recognized, however, that most patients require additional lip surgeries for an optimum esthetic result. Clinicians often disagree as to when this end point is reached since the decision for additional lip revision is based on subjective clinical assessments.
Facial morphology during function has a major impact on how a person is perceived in society and is known to be an important component of the esthetic outcome for cleft patients, but it has been particularly difficult to incorporate measures of lip function into the decision-making process. It is likely that the different surgical procedures for both primary lip closure and secondary lip revision could be improved if the effects of alternative surgical techniques on function were better understood. The subjects for this project consist of two cleft lip and palate patient groups treated at the University of North Carolina (UNC) Craniofacial Center: one cleft group will be patients who are candidates for additional lip revision surgery; the other cleft group will be patients who have been judged not to need lip revision; and a matched non-cleft group who present for routine dental care at UNC School of Dentistry. The goals of this project are to objectively measure and quantify functional facial impairment in cleft patients, and to establish more reliable, functionally relevant outcome criteria for treatment planning and evaluation of these individuals. Our specific aims, therefore, are to
1. In a prospective non-randomized controlled clinical trial, evaluate the efficacy of lip revision surgery by a) Examining longitudinal changes in function after lip revision, and b) Examining whether the change in function after lip revision differs from the change that would be observed due to maturation only in the matched non-cleft 'normal' group, and the change in the cleft but non-lip revised group.
2. a) Estimate the effect of cleft lip and palate on function after primary lip and palate repair but prior to lip revision surgery by comparing those patients scheduled to receive a lip revision with those who are judged not to need a lip revision, and b) Estimate the impairment in function in cleft lip and palate patients without lip revision relative to matched non-cleft subjects.
3. Compare the assessments of dynamic lip function provided by objective measures with subjective clinical judgments/ratings of craniofacial plastic surgeons who perform lip revision surgery, and evaluate the potential of the new methods for clinical application.
4. Evaluate whether objective information when added to the clinician's subjective evaluation of a patient alters the surgical treatment plan or the goals of treatment when subjective and objective information are incorporated in the decision-making and treatment planning process. This specific aim will be useful in adapting and assessing the potential of the new objective methods for application in a clinical setting.
5. To establish 'parameters of care' criteria for secondary lip revision treatment decision-making based on standardized, systematic subjective evaluation, and an objective measurement of movement capacity during function of the upper lip.
6. Assess the long-term effects of maturation on function following lip revision by continuing data-collection beyond the one-year post-revision on patients recruited during the period of the initial grant and long-term follow-up (18 and 30 months) on newly recruited lip revision patients, and in so doing, evaluate the efficacy of cleft lip revision surgery.
To address these aims, we have identified a group of highly qualified individuals with widely recognized expertise in the application of the proposed methodologies, and a panel of surgeons experienced in cleft care for clinical evaluation of outcomes. This expertise, the availability of an appropriate patient resource, and the home institution's 40-year history of strong commitment to the care of these patients and craniofacial research, all favor success in meeting the goals of the project.
Facial morphology during function has a major impact on how a person is perceived in society and is known to be an important component of the esthetic outcome for cleft patients, but it has been particularly difficult to incorporate measures of lip function into the decision-making process. It is likely that the different surgical procedures for both primary lip closure and secondary lip revision could be improved if the effects of alternative surgical techniques on function were better understood. The subjects for this project consist of two cleft lip and palate patient groups treated at the University of North Carolina (UNC) Craniofacial Center: one cleft group will be patients who are candidates for additional lip revision surgery; the other cleft group will be patients who have been judged not to need lip revision; and a matched non-cleft group who present for routine dental care at UNC School of Dentistry. The goals of this project are to objectively measure and quantify functional facial impairment in cleft patients, and to establish more reliable, functionally relevant outcome criteria for treatment planning and evaluation of these individuals. Our specific aims, therefore, are to
1. In a prospective non-randomized controlled clinical trial, evaluate the efficacy of lip revision surgery by a) Examining longitudinal changes in function after lip revision, and b) Examining whether the change in function after lip revision differs from the change that would be observed due to maturation only in the matched non-cleft 'normal' group, and the change in the cleft but non-lip revised group.
2. a) Estimate the effect of cleft lip and palate on function after primary lip and palate repair but prior to lip revision surgery by comparing those patients scheduled to receive a lip revision with those who are judged not to need a lip revision, and b) Estimate the impairment in function in cleft lip and palate patients without lip revision relative to matched non-cleft subjects.
3. Compare the assessments of dynamic lip function provided by objective measures with subjective clinical judgments/ratings of craniofacial plastic surgeons who perform lip revision surgery, and evaluate the potential of the new methods for clinical application.
4. Evaluate whether objective information when added to the clinician's subjective evaluation of a patient alters the surgical treatment plan or the goals of treatment when subjective and objective information are incorporated in the decision-making and treatment planning process. This specific aim will be useful in adapting and assessing the potential of the new objective methods for application in a clinical setting.
5. To establish 'parameters of care' criteria for secondary lip revision treatment decision-making based on standardized, systematic subjective evaluation, and an objective measurement of movement capacity during function of the upper lip.
6. Assess the long-term effects of maturation on function following lip revision by continuing data-collection beyond the one-year post-revision on patients recruited during the period of the initial grant and long-term follow-up (18 and 30 months) on newly recruited lip revision patients, and in so doing, evaluate the efficacy of cleft lip revision surgery.
To address these aims, we have identified a group of highly qualified individuals with widely recognized expertise in the application of the proposed methodologies, and a panel of surgeons experienced in cleft care for clinical evaluation of outcomes. This expertise, the availability of an appropriate patient resource, and the home institution's 40-year history of strong commitment to the care of these patients and craniofacial research, all favor success in meeting the goals of the project.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Cleft Lip
Cleft Lip and Palate
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Revision
Patients with repaired cleft lip who receive lip revision surgery
Lip revision surgery
Intervention Type
PROCEDURE
Full or partial muscle thickness lip revision surgery.
Non-Revision
Patients with repaired cleft lip who do not have lip revision surgery
No interventions assigned to this group
Non-cleft
Non-cleft 'control' subjects.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lip revision surgery
Full or partial muscle thickness lip revision surgery.
Intervention Type
PROCEDURE
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Primary lip repair
Secondary lip repair
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* Patient interest / parent willingness to participate in the study;
* An ability to comprehend verbal instructions; and
* An age range of 5-17 yrs.
* The professional clinical recommendation by the Center's craniofacial plastic surgeon for a cleft lip repair surgery;
* Parent willingness to have baby participate in the study;
* An age range of 0-6 months.
* Parent willingness to have baby participate in the study;
* An age range of 0-6 months.
* 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.
* Patient interest / parent willingness to participate in the study;
* An ability to comprehend verbal instructions; and
* An age range of 5-17 yrs.
* The professional clinical recommendation by the Center's craniofacial plastic surgeon for a cleft lip repair surgery;
* Parent willingness to have baby participate in the study;
* An age range of 0-6 months.
* Parent willingness to have baby participate in the study;
* An age range of 0-6 months.
Exclusion Criteria
* 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.
* 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.
2. Infants
Cleft lip and palate patients.
* Has had surgery for any reason
* A diagnosis of a craniofacial anomaly other than cleft lip and palate;
* A medical history of diabetes, collagen vascular disease, and systemic neurologic impairment
Non-cleft subjects.
* Has had surgery for any reason including bone surgery
* A medical history of diabetes, collagen vascular disease, and systemic neurological impairment
* 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.
* 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.
2. Infants
Cleft lip and palate patients.
* Has had surgery for any reason
* A diagnosis of a craniofacial anomaly other than cleft lip and palate;
* A medical history of diabetes, collagen vascular disease, and systemic neurologic impairment
Non-cleft subjects.
* Has had surgery for any reason including bone surgery
* A medical history of diabetes, collagen vascular disease, and systemic neurological impairment
Minimum Eligible Age
3 Months
Maximum Eligible Age
21 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Dental and Craniofacial Research (NIDCR)
NIH
Sponsor Role
collaborator
University of North Carolina, Chapel Hill
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Carroll-ann Trotman, DDS
Adjunct Professor, Department of Orthodontics
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carroll-Ann Trotman, BDS, MA, MS
Role: PRINCIPAL_INVESTIGATOR
University of NC at Chapel Hill
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NIDCR-13814
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Three-dimensional Cleft Lip and Palate Morphology Prior to One-stage Cleft Repair
NCT04616690
COMPLETED
An Investigation for the Optimal Timing of a Cleft Palate Repair
NCT00779961
UNKNOWN
NA
Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty
NCT03839290
UNKNOWN
A Proposal for a New Classification of Secondary Cleft Lip and Nose Deformities in Repaired Unilateral Cleft Lip
NCT04972370
COMPLETED
Otologic and Rhinologic Outcomes in Children With Clef Palate
NCT03708406
COMPLETED
Targeting Surgeons' Decision-Making for Cleft Lip Surgery
NCT03537976
ACTIVE_NOT_RECRUITING
NA
Computational Modeling of Cleft Lip Nasal Deformity and Assessment of Nasal Function and Treatment Outcomes
NCT04150783
COMPLETED
A Study to Examine the Relationship Between Sleep Apnea and Cleft Lip/Palate
NCT00156442
COMPLETED
Evaluation of Quality of Life After Orthognathic Surgery in a Cleft Lip and Palate Context
NCT04049058
UNKNOWN
Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate
NCT05081258
RECRUITING
NA
Relational Development in Children With Cleft Lips and Palates: Influence of the Waiting Period Prior to the First Surgical Intervention and the Parents' Psychological Perception of the Abnormality
NCT00993993
COMPLETED
Efficacy of Maxillo-facial Treatment on Cleft Lip and Palate Patients Faces: Aesthetic Considerations
NCT03395015
COMPLETED
Assessment of the Influence of Cleft Repair on Microcirculation of the Palate
NCT03877666
RECRUITING
Sleep and Behavior in Children With Cleft Palate
NCT01046591
COMPLETED
Systematic Pediatric Care for Oral Clefts - South America
NCT00097149
COMPLETED
NA
Evaluation of Facial Growth in Two Primary Protocols Used in the Surgical Treatment of Unilateral Cleft Lip and Palate Patients
NCT02329509
COMPLETED
NA
Prosthetic Rehabilitation of Lip and Palate Deformaties in Neonates Using Two Different Approaches
NCT06522217
COMPLETED
NA
Clinical Application of Artificial Intelligence in New Borns With Cleft Lip and Palate
NCT06970158
RECRUITING
NA
Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q
NCT05775679
RECRUITING
Neural Network to Calculate Morphology of the Cleft Palate to Reduce Cleft Lip and Palate Treatment Burden.
NCT04342234
RECRUITING
Biochemical and Histological Comparison of Nasal and Auricular Cartilage in the Fetus and Newborn With Cleft Lip Carrier
NCT02505360
UNKNOWN
NA
Effect of Neck Extension on Intraocular Pressure in Patients Undergoing Palatoplasty
NCT04683978
COMPLETED
Prospective Evaluation of Speech Function Through Patient- and Parent-response Outcome Measurements in Velopharyngeal Insufficiency
NCT05838261
RECRUITING
Cleft Palate Surgical Simulator: Improvement in Surgical Trainees' Knowledge and Confidence.
NCT04489680
COMPLETED
NA