Cleft LipNCT00070811
Assessing the Results of Lip Surgery in Patients With Cleft Lip and Palate
An observational study of Cleft Lip and Cleft Lip and Palate, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip, Cleft Lip and Palate
- What is being tested?
- Lip revision surgery
- Type of treatment
- Surgery or procedure
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7450
About this study
Official title: Functional Outcomes of Cleft Lip and Lip Revision Surgery
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.
Read the detailed description
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- Cleft Lip, Cleft Lip and Palate
- Being tested
- Lip revision surgery
- Keywords
- Facial form, Facial animation, Lip muscle reconstruction, Lip form, Lip function
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lip revision surgeryProcedure or surgery
Also called Primary lip repair, Secondary lip repair
Full or partial muscle thickness lip revision surgery.
| Study group | Role | What they receive |
|---|---|---|
| Revision | Patients with repaired cleft lip who receive lip revision surgery Receives: Procedure: Lip revision surgery | |
| Non-Revision | Patients with repaired cleft lip who do not have lip revision surgery | |
| Non-cleft | Non-cleft 'control' subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial movement/animation
Measured: 6
Secondary outcomes (3)
Lip Force
Measured: 6
EMG
Measured: 6
Lip sensation
Measured: 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2003 (estimated)
- Study startAug 2001
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Cleft LipStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Carroll-ann Trotman, DDS, University of North Carolina, Chapel Hill
- Investigators
- Carroll-Ann Trotman, BDS, MA, MS, Principal investigator, University of NC at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070811
- Sponsor's protocol ID
- NIDCR-13814
- Other IDs
- R01DE013814
- Status last verified
- Jul 2013
- First submitted
- 8 Oct 2003
- Last updated
- 4 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19717653Trotman 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.
PubMed 10744215Trotman 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.
PubMed 9527310Trotman 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.
PubMed 9527311Liu 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.
PubMed 22902812Liu 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.
PubMed 22697426Trotman 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.
PubMed 18177192Trotman 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.
PubMed 18177193Essick 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.
PubMed 18177194Trotman 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.
PubMed 18177195Trotman 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.
PubMed 15865457Essick 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.
PubMed 15748109Trotman 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.
PubMed 12733951Ritter 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.
PubMed 12401105Lee 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.
PubMed 15529491
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes of Cleft Lip and Lip Revision Surgery
- ClinicalTrials.gov ID
- NCT00070811
- Acronym / sponsor ID
- NIDCR-13814
- Conditions
- Cleft Lip, Cleft Lip and Palate
- Keywords
- Facial form, Facial animation, Lip muscle reconstruction, Lip form, Lip function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Aug 2001
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Revision | – | Procedure: Lip revision surgeryPatients with repaired cleft lip who receive lip revision surgery |
| Non-Revision | – | –Patients with repaired cleft lip who do not have lip revision surgery |
| Non-cleft | – | –Non-cleft 'control' subjects. |
Who may qualify
- Ages
- 3 months to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (18 listed)
- Non-cleft subjects.
- Infants
- Cleft lip and palate patients.
- Has had surgery for any reason
- A diagnosis of a craniofacial anomaly other than cleft lip and palate;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lip revision surgeryAlso: Primary lip repair, Secondary lip repairFull or partial muscle thickness lip revision surgery. | Procedure or surgery | Revision |
Primary outcome
Facial movement/animation
Time frame: 6
3 secondary outcomes
Lip Force
Time frame: 6
EMG
Time frame: 6
Lip sensation
Time frame: 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2013.
- Background: PubMed 19717653Andreatta 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.
- Background: PubMed 10744215Trotman 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.
- Background: PubMed 9527310Trotman 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.
- Background: PubMed 9527311Trotman 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.
- Background: PubMed 22902812Liu 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.
- Background: PubMed 22697426Liu 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.
- Results publication: PubMed 18177192Trotman 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.
- Results publication: PubMed 18177193Trotman 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.
- Results publication: PubMed 18177194Essick 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.
- Results publication: PubMed 18177195Trotman 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.
- Results publication: PubMed 15865457Trotman 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.
- Results publication: PubMed 15748109Essick 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carroll-Ann Trotman, BDS, MA, MS principal investigator
University of NC at Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Lip and Cleft Lip and Palate, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial movement/animation (time frame: 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00070811, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2013.