Cleft Lip and PalatePROTRACTSURGNCT02789787
Clinical Effectiveness of Late Maxillary Protraction for Cleft Lip and Palate
An observational study of Cleft Lip and Palate, run by University of Southern California at 2 sites in United States.
Trial summary
Patients with cleft lip and palate frequently develop Class III (Cl III) malocclusions or underbites following early cleft repair surgeries. This clinical trial compares the current standard of care for treating the Cl III malocclusion, orthognathic (jaw) surgery after pubertal growth (16-21 years), with an… Read more about this study
- Who is it for?
- Ages 11 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Maxillary Protraction and Orthognathic Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 117 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Apr 2015to 31 May 2021
- 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 11 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients with nonsyndromic cleft lip and palate who have a Cl III malocclusion
Who may be able to join
- Diagnosis of nonsyndromic cleft lip and palate and Class III malocclusion
- Age 11-14 for maxillary protraction, Age 16-21 for LeFort I single jaw surgery.
Who cannot join
- Cognitive delay;
- Mandibular asymmetry;
- Mandibular prognathism;
- 2-jaw cants;
- Non-grafted alveolar cleft;
- Inability or unwillingness to have clinical radiographs, photographs, or dental impressions taken;
- History of therapeeutic radiation treatment to the mazilla or mandible;
- Pregnancy; if participants become pregnant during the study they will be withdrawn.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital Los Angeles
Los Angeles, California, 90027
Seattle Children's Hospital
Seattle, Washington, 981105
About this study
Patients with cleft lip and palate frequently develop Class III (Cl III) malocclusions or underbites following early cleft repair surgeries. This clinical trial compares the current standard of care for treating the Cl III malocclusion, orthognathic (jaw) surgery after pubertal growth (16-21 years), with an alternative orthopedic approach to protract the maxilla during adolescence (11-14 years). At Children's Hospital Los Angeles(CHLA), early adolescents with cleft lip and palate and Cl III malocclusion are offered an alternative non-surgical approach to correct the malocclusion called "maxillary protraction". Prior to age 14, the maxillary sutures have not fused and can be mobilized by alternating weekly expansion and constriction with a rapid palatal expander (RPE), thereby allowing the upper jaw (maxilla) to be pulled forward (protracted) to correct the underbite. This prospective parallel cohort study will assess the patients undergoing treatment for the Cl III malocclusion by either orthognathic surgery or maxillary protraction at four data collection time points during treatment. The data includes digitized study models, photographs and radiographs, quality of life surveys (SF12, YQOL), parent surveys (ASEBA), treatment cost, periodontal measurements and treatment complications. The study design is a descriptive cohort study that examines the success of treatment (% not requiring a second surgery), the dental and skeletal changes associated with treatment, the stability of treatment and the behavioural/adaptive factors (ASEBA) that contribute to success and lack of success for each treatment. The primary trial will be conducted at Children's Hospital Los Angeles and a pilot study to confirm translation to different settings will be conducted at Seattle Children's Hospital.
Read the detailed description
Rationale: Cleft lip and palate is the most common facial birth defect. Patients with cleft lip and palate frequently develop Class III (Cl III) malocclusion or underbites for which the current standard of care to treat the Cl III malocclusion is orthognathic (jaw) surgery. Orthognathic surgery is performed late in a teenager's life after pubertal growth is complete, has a long recovery period, has risks for segment loss and nerve injury and is expensive to the insurers. Moreover, the surgical correction can relapse and require a second jaw surgery.
Intervention: The current standard of care for correcting a Cl III malocclusion is orthognathic surgery after pubertal growth is complete. At Children's Hospital, early adolescents (11 - 14 yrs) with cleft lip and palate and Cl III malocclusion are offered an alternative non-surgical approach to correct the malocclusion called "maxillary protraction". At ages 11- 14, the maxillary sutures have not fused and can be mobilized by alternating weekly expansion and constriction with a rapid palatal expander (RPE), thereby allowing the upper jaw (maxilla) to be pulled forward (protracted) in order to correct the underbite.
Purpose: This study will compare the occlusal, photographic, radiographic, periodontal and quality of life data collected at four different timepoints from patients who were treated for the correction of their Cl III malocclusion by either LeFort I maxillary advancement surgery or non-surgical maxillary protraction.
Study Population: The inclusion criteria are patients who are diagnosed with isolated cleft lip and palate with Cl III malocclusion and who, at the time of enrollment, do not have any medical condition which will prevent them from undergoing orthognathic surgery or maxillary protraction procedures. The two study groups differ in age and treatment. One group of patients, ages 11 -14 years of age, chose to undergo maxillary protraction via sutural loosening for correction of Cl III malocclusion. The other group of patients, ages 16 and 21 years, elected to undergo orthognathic surgery for correction of Cl III malocclusion.
Study Methodology: This is a non-randomized prospective parallel cohort study that follows the treatment outcomes of approximately 100 patients with cleft lip and palate and Cl III malocclusion who are treated with maxillary protraction at about a maximal age of 14 years (target N=50) vs. orthognathic surgery at a maximal age of 21 years (target N=50).
Description of Treatment Arms: The first treatment arm consists of participants who have chosen to undergo the orthodontic (non-surgical) maxillary protraction procedure. The second treatment arm consists of participants who have chosen to undergo the orthognathic (jaw) surgical procedure.
Outcomes: The outcomes measured in both groups will be bite correction (GOSLON yardstick), facial esthetics, changes in cephalometric x-ray measurements, youth quality of life (YQOL), psychological/behavioral assessment surveys (ASEBA), cost, periodontal health, complications and stability of treatment.
Follow-up: Participants in both arms of the study (protraction vs. surgery) will have data collected prior to, during, immediately after, and 1 year after treatment.
Statistics and Plans for Analysis: The % of patients requiring further surgery and the reasons for the relapse or incomplete treatment will be examined using the collected data. The investigators will examine factors that are associated with the successful outcomes for each treatment and adjust for these factors in the models.
- Conditions
- Cleft Lip and Palate
- Being tested
- Maxillary Protraction, Orthognathic Surgery
- Keywords
- Cleft Lip, Palate, Class III, Malocclusion, Protraction
- Medical subject headings
- Cleft Lip, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary ProtractionProcedure or surgery
"Maxillary protraction" is an alternative non-surgical approach to correct the Cl III malocclusion. At ages 11- 14, the maxillary sutures have not fused and can be mobilized by alternating weekly expansion and constriction with a rapid palatal expander (RPE), thereby allowing the maxilla to be protracted in order to correct the underbite. This treatment is offered to the patients, age 11-14, who have the Cl III malocclusion with or without cleft lip and palate.
Orthognathic SurgeryProcedure or surgery
Also called LeFort 1 maxillary advancement surgery
The orthognathic surgery is the current standard of care for treating the Cl III malocclusion after pubertal growth. This treatment is offered to the patients, after pubertal growth, who have the Cl III malocclusion with or without cleft lip and palate.
| Study group | Role | What they receive |
|---|---|---|
| Maxillary protraction | Early adolescents (11 - 14 yrs) with cleft lip and palate and Cl III malocclusion Receives: Procedure: Maxillary Protraction | |
| Orthognathic surgery | Late adolescents to young adults (16-21 years) with cleft lip and palate and Cl III malocclusion Receives: Procedure: Orthognathic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bite correction of digitized models.
The metric for comparing the difference in bite using study models from patients with cleft lip and palate is the "GOSLON Yardstick" which can rate antero-posterior as well as transverse positions.
Measured: Approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
Secondary outcomes (7)
Cephalometric radiographs
The cephalometric radiographs from the different time points are stored in Dolphin imaging software and digitized for orthodontic and surgical cephalometric analyses. This type of analysis can examine differences between skeletal vs. dental changes between time points.
Measured: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
Facial attractive rating of photographs
The pre-treatment and post-treatment facial photographs of all of the patients in the study will be randomly presented for rating using an analog scale for facial attractiveness. The photographs are presented in a secure database file within the hospital to lay and clinician raters for evaluating the photographs. This type of rating survey can provide data on amount and direction of facial change with each treatment.
Measured: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
Costs of treatments
The number of visits and current procedural terminology(CPT) codes for the visits will be used to define cost units. The actual costs for CHLA and SCH will be calculated by assigning the hospital charges for those CPT codes.
Measured: At the end of approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
12-Item Short Form Health Survey (SF-12) developed by the Rand Corporation
The SF-12 is a short form standardized instrument for medical outcome study.
Measured: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
Youth Quality of Life (YQOL) survey designed by the Seattle Quality of Life Group
The YQOL instrument assesses multidimensionally the generic quality of life of youth ages 11-18 years of age. YQOL includes both generic and condition-specific measures.
Measured: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
Achenbach System of Empirically Based Assessment (ASEBA)
The ASEBA offers a comprehensive approach to assessing adaptive and maladaptive functioning.These surveys are given to the parents of the patients in the study in order to provide a behavioural assessment of their child.
Measured: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
Periodontal measurements
The periodontal condition of the premolars and molars normally used for maxillary protraction are evaluated using bleeding index, plaque scores, probe depth and mobility scores.
Measured: Approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study start29 Apr 2015
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Seattle Children's Hospital, Children's Hospital Los Angeles
- Responsible party
- Principal investigator, Stephen Yen, University of Southern California
- Investigators
- Stephen Yen, DMD, PhD, Principal investigator, CHLAJane Atkinson, Study director, National Institute of Dental and Craniofacial Research (NIDCR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789787
- Sponsor's protocol ID
- 5U01DE022937-04
- Acronym
- PROTRACTSURG
- Status last verified
- Oct 2021
- First submitted
- 9 May 2016
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All of the participant data collected during the trial after deidentification
Publications
Chung EH, Borzabadi-Farahani A, Yen SL. Clinicians and laypeople assessment of facial attractiveness in patients with cleft lip and palate treated with LeFort I surgery or late maxillary protraction. Int J Pediatr Otorhinolaryngol. 2013 Sep;77(9):1446-50. doi: 10.1016/j.ijporl.2013.05.042. Epub 2013 Jul 18.
PubMed 23871270Yen SL. Protocols for Late Maxillary Protraction in Cleft Lip and Palate Patients at Childrens Hospital Los Angeles. Semin Orthod. 2011 Jun 1;17(2):138-148. doi: 10.1053/j.sodo.2011.01.001.
PubMed 21765629McIlvaine E, Borzabadi-Farahani A, Lane CJ, Azen SP, Yen SL. Apriori feasibility testing of randomized clinical trial design in patients with cleft deformities and Class III malocclusion. Int J Pediatr Otorhinolaryngol. 2014 May;78(5):725-30. doi: 10.1016/j.ijporl.2014.01.006. Epub 2014 Feb 12.
PubMed 24630053Borzabadi-Farahani A, Lane CJ, Yen SL. Late maxillary protraction in patients with unilateral cleft lip and palate: a retrospective study. Cleft Palate Craniofac J. 2014 Jan;51(1):e1-e10. doi: 10.1597/12-099. Epub 2012 Dec 13.
PubMed 23237432
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Late Maxillary Protraction for Cleft Lip and Palate
- ClinicalTrials.gov ID
- NCT02789787
- Acronym / sponsor ID
- PROTRACTSURG / 5U01DE022937-04
- Conditions
- Cleft Lip and Palate
- Keywords
- Cleft Lip, Palate, Class III, Malocclusion, Protraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Seattle Children's Hospital, Children's Hospital Los Angeles
- Study start
- 29 Apr 2015 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 3 Jun 2016 (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.
Patients with cleft lip and palate frequently develop Class III (Cl III) malocclusions or underbites following early cleft repair surgeries. This clinical trial compares the current standard of care for treating the Cl III malocclusion, orthognathic (jaw) surgery after pubertal growth (16-21 years), with an alternative orthopedic approach to protract the maxilla during adolescence (11-14 years). At Children's Hospital Los Angeles(CHLA), early adolescents with cleft lip and palate and Cl III malocclusion are offered an alternative non-surgical approach to correct the malocclusion called "maxillary protraction". Prior to age 14, the maxillary sutures have not fused and can be mobilized by alternating weekly expansion and constriction with a rapid palatal expander (RPE), thereby allowing the upper jaw (maxilla) to be pulled forward (protracted) to correct the underbite. This prospective parallel cohort study will assess the patients undergoing treatment for the Cl III malocclusion by either orthognathic surgery or maxillary protraction at four data collection time points during treatment. The data includes digitized study models, photographs and radiographs, quality of life surveys (SF12, YQOL), parent surveys (ASEBA), treatment cost, periodontal measurements and treatment complications. The study design is a descriptive cohort study that examines the success of treatment (% not requiring a second surgery), the dental and skeletal changes associated with treatment, the stability of treatment and the behavioural/adaptive factors (ASEBA) that contribute to success and lack of success for each treatment. The primary trial will be conducted at Children's Hospital Los Angeles and a pilot study to confirm translation to different settings will be conducted at Seattle Children's Hospital.
Detailed description
Rationale: Cleft lip and palate is the most common facial birth defect. Patients with cleft lip and palate frequently develop Class III (Cl III) malocclusion or underbites for which the current standard of care to treat the Cl III malocclusion is orthognathic (jaw) surgery. Orthognathic surgery is performed late in a teenager's life after pubertal growth is complete, has a long recovery period, has risks for segment loss and nerve injury and is expensive to the insurers. Moreover, the surgical correction can relapse and require a second jaw surgery.
Intervention: The current standard of care for correcting a Cl III malocclusion is orthognathic surgery after pubertal growth is complete. At Children's Hospital, early adolescents (11 - 14 yrs) with cleft lip and palate and Cl III malocclusion are offered an alternative non-surgical approach to correct the malocclusion called "maxillary protraction". At ages 11- 14, the maxillary sutures have not fused and can be mobilized by alternating weekly expansion and constriction with a rapid palatal expander (RPE), thereby allowing the upper jaw (maxilla) to be pulled forward (protracted) in order to correct the underbite.
Purpose: This study will compare the occlusal, photographic, radiographic, periodontal and quality of life data collected at four different timepoints from patients who were treated for the correction of their Cl III malocclusion by either LeFort I maxillary advancement surgery or non-surgical maxillary protraction.
Study Population: The inclusion criteria are patients who are diagnosed with isolated cleft lip and palate with Cl III malocclusion and who, at the time of enrollment, do not have any medical condition which will prevent them from undergoing orthognathic surgery or maxillary protraction procedures. The two study groups differ in age and treatment. One group of patients, ages 11 -14 years of age, chose to undergo maxillary protraction via sutural loosening for correction of Cl III malocclusion. The other group of patients, ages 16 and 21 years, elected to undergo orthognathic surgery for correction of Cl III malocclusion.
Study Methodology: This is a non-randomized prospective parallel cohort study that follows the treatment outcomes of approximately 100 patients with cleft lip and palate and Cl III malocclusion who are treated with maxillary protraction at about a maximal age of 14 years (target N=50) vs. orthognathic surgery at a maximal age of 21 years (target N=50).
Description of Treatment Arms: The first treatment arm consists of participants who have chosen to undergo the orthodontic (non-surgical) maxillary protraction procedure. The second treatment arm consists of participants who have chosen to undergo the orthognathic (jaw) surgical procedure.
Outcomes: The outcomes measured in both groups will be bite correction (GOSLON yardstick), facial esthetics, changes in cephalometric x-ray measurements, youth quality of life (YQOL), psychological/behavioral assessment surveys (ASEBA), cost, periodontal health, complications and stability of treatment.
Follow-up: Participants in both arms of the study (protraction vs. surgery) will have data collected prior to, during, immediately after, and 1 year after treatment.
Statistics and Plans for Analysis: The % of patients requiring further surgery and the reasons for the relapse or incomplete treatment will be examined using the collected data. The investigators will examine factors that are associated with the successful outcomes for each treatment and adjust for these factors in the models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maxillary protraction | – | Procedure: Maxillary ProtractionEarly adolescents (11 - 14 yrs) with cleft lip and palate and Cl III malocclusion |
| Orthognathic surgery | – | Procedure: Orthognathic SurgeryLate adolescents to young adults (16-21 years) with cleft lip and palate and Cl III malocclusion |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients with nonsyndromic cleft lip and palate who have a Cl III malocclusion
Key inclusion criteria (2 listed)
- Diagnosis of nonsyndromic cleft lip and palate and Class III malocclusion
- Age 11-14 for maxillary protraction, Age 16-21 for LeFort I single jaw surgery.
Key exclusion criteria (8 listed)
- Cognitive delay;
- Mandibular asymmetry;
- Mandibular prognathism;
- 2-jaw cants;
- Non-grafted alveolar cleft;
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 |
|---|---|---|
| Maxillary Protraction"Maxillary protraction" is an alternative non-surgical approach to correct the Cl III malocclusion. At ages 11- 14, the maxillary sutures have not fused and can be mobilized by alternating weekly expansion and constriction with a rapid palatal expander (RPE), thereby allowing the maxilla to be protracted in order to correct the underbite. This treatment is offered to the patients, age 11-14, who have the Cl III malocclusion with or without cleft lip and palate. | Procedure or surgery | Maxillary protraction |
| Orthognathic SurgeryAlso: LeFort 1 maxillary advancement surgeryThe orthognathic surgery is the current standard of care for treating the Cl III malocclusion after pubertal growth. This treatment is offered to the patients, after pubertal growth, who have the Cl III malocclusion with or without cleft lip and palate. | Procedure or surgery | Orthognathic surgery |
Primary outcome
Bite correction of digitized models.
Time frame: Approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
The metric for comparing the difference in bite using study models from patients with cleft lip and palate is the "GOSLON Yardstick" which can rate antero-posterior as well as transverse positions.
7 secondary outcomes
Cephalometric radiographs
Time frame: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
Facial attractive rating of photographs
Time frame: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
Costs of treatments
Time frame: At the end of approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
12-Item Short Form Health Survey (SF-12) developed by the Rand Corporation
Time frame: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
Youth Quality of Life (YQOL) survey designed by the Seattle Quality of Life Group
Time frame: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
Achenbach System of Empirically Based Assessment (ASEBA)
Time frame: The four timepoints during approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
Periodontal measurements
Time frame: Approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.
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 11 Oct 2021.
- Background: PubMed 23871270Chung EH, Borzabadi-Farahani A, Yen SL. Clinicians and laypeople assessment of facial attractiveness in patients with cleft lip and palate treated with LeFort I surgery or late maxillary protraction. Int J Pediatr Otorhinolaryngol. 2013 Sep;77(9):1446-50. doi: 10.1016/j.ijporl.2013.05.042. Epub 2013 Jul 18.
- Background: PubMed 21765629Yen SL. Protocols for Late Maxillary Protraction in Cleft Lip and Palate Patients at Childrens Hospital Los Angeles. Semin Orthod. 2011 Jun 1;17(2):138-148. doi: 10.1053/j.sodo.2011.01.001.
- Background: PubMed 24630053McIlvaine E, Borzabadi-Farahani A, Lane CJ, Azen SP, Yen SL. Apriori feasibility testing of randomized clinical trial design in patients with cleft deformities and Class III malocclusion. Int J Pediatr Otorhinolaryngol. 2014 May;78(5):725-30. doi: 10.1016/j.ijporl.2014.01.006. Epub 2014 Feb 12.
- Results publication: PubMed 23237432Borzabadi-Farahani A, Lane CJ, Yen SL. Late maxillary protraction in patients with unilateral cleft lip and palate: a retrospective study. Cleft Palate Craniofac J. 2014 Jan;51(1):e1-e10. doi: 10.1597/12-099. Epub 2012 Dec 13.
- Individual participant dataSharing planned: Yes. All of the participant data collected during the trial after deidentification
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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.
Stephen Yen, DMD, PhD principal investigator
CHLA
Jane Atkinson study director
National Institute of Dental and Craniofacial Research (NIDCR)
2 sites 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 Palate, run by University of Southern California at 2 sites 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 2 inclusion and 8 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 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Bite correction of digitized models. (time frame: Approximately 36-48 months for maxillary protraction patients and approximately 36-42 months for patients undergoing orthognathic surgery.). 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 NCT02789787, which also lists 4 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 11 Oct 2021; AzTrials last refreshed its copy on 7 Nov 2026.