Cleft LipNCT04334590
Fabrication of Sequential Naso-Alveolar Molding Appliances in the Treatment of Cleft Lip/Nose Deformities
An observational study of Cleft Lip and Congenital Nose Malformation, run by Johns Hopkins University at 1 site in United States.
Trial summary
There is a robust body of research suggesting that the use of pre-surgical orthopedic devices prior to definitive cleft lip/nose repair results in significant improvement of facial aesthetics with long term follow up. Read more about this study
- Who is it for?
- Ages 0 months to 1 month
- Conditions the study is for
- Cleft Lip, Congenital Nose Malformation, Deformity
- What is being tested?
- Cleft Lip/Nose Repair without PSIO and Presurgical Infant Orthopedic Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2020to Apr 2022
- 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 0 months to 1 month
- All sexes
- No healthy volunteers
- Child
Study population: Newborns either born in Johns Hopkins or presenting to clinic with a cleft lip between 0-1 months of life.
Who may be able to join
- All newborns either born in Johns Hopkins or presenting to clinic with a cleft lip between 0-1 months of life
Who cannot join
- Patients older than one month of age at presentation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Surgical Planning for the Fabrication of Sequential Naso-Alveolar Molding Appliances in the Treatment of Cleft Lip/Nose Deformities
There is a robust body of research suggesting that the use of pre-surgical orthopedic devices prior to definitive cleft lip/nose repair results in significant improvement of facial aesthetics with long term follow up. However, in recent surveys of the cleft centers in the US, only 30% of cleft centers offer PSIOs, and only 13% routinely report its use. Accordingly, thirty percent of centers utilize a two-stage cleft lip/nose repair in the centers' algorithm (1st: lip adhesion; 2nd: final lip repair). The major drawback to a two-stage cleft procedure is the administration of two general anesthetics to an infant before the age of one year. There is a growing amount of evidence that multiple anesthetic experiences before a certain age could affect brain development.
It is difficult to make inferences as to why clinicians are not utilizing surgical aids to decrease the size of the cleft width, but even when PSIO is offered, caregivers experience additional, potentially prohibitive challenges. In one study, caregivers traveled an average of 70 miles to visit the nearest cleft center offering pre-surgical orthopedic devices. As these devices are created by hand every 1-2 weeks after seeing the child in clinic, parents are required to travel to clinic multiple times per month. Not surprisingly, infants who were first-born and those who did not have other siblings were more likely to receive pre-surgical orthopedic treatment than infants who were residing with other siblings.
Read more
Given the benefits of PSIOs and the barriers both to healthcare systems and patients' families associated with PSIOs in its current form, a new form of pre-surgical clinical management is needed.
Objectives:
- Evaluate JHH's current clinical performance in addressing unilateral cleft lip and nasal deformity.
- Elucidate the difference in preoperative cleft size and in surgical management/outcomes for patients who received PSIOs through 3D-printed devices.
- Using the above maxillofacial growth data with and without PSIOs, the investigators aim to create an algorithm to predict maxillofacial growth for each individual patient to design pre-sequenced custom PSIO devices.
Read the detailed description
Approximately 7000 babies are born with a cleft lip and/or cleft palate in the United States per year. Globally, this defect is staggeringly common, with 100,000 new cases per year. This defect is due to a failure of normal fusion between facial structures, causing a full thickness gap of the upper lip involving skin, muscle, and other connective tissue. Due to aberrant insertion of the muscle underlying the lip as well as abnormal formation of deeper facial structures, the nose is also displaced inferiorly, laterally, and posteriorly. The wider the cleft, the more challenging the repair.
Current best practice in treating unilateral cleft lip and nose deformity involves presurgical infant orthopedics (PSIOs). PSIOs involves presurgically treating the deformity using custom orthodontics to gradually bring the two halves of the cleft together, reducing defect size and enabling complete repair with one surgery during early infancy. However, creation of these molds is time consuming and requires the expertise of a cleft orthodontist and weekly visits to the hospital for device advancement. As not all cleft centers have a specialized cleft orthodontist-including Johns Hopkins Hospital-many are unable to provide presurgical infant orthopedics. Weekly travel to cleft centers can also pose a significant temporal and financial burden to families, as the average patient is located over 60 miles from the nearest cleft center. In a recent survey of cleft centers in the United States, only 30% of these centers are able to provide presurgical orthopedic molding devices in treatment protocols. These centers therefore correct wide clefts with a staged, two-surgery approach. This approach is often less successful in both adequately aligning the gum and in repairing nasal defects, and usually requires intensive orthodontics and additional surgeries in adolescence. As the defect is not fully corrected in infancy, children are additionally subjected to the emotional and psychological difficulty and damage to self-esteem associated with the persistent defect.
With the advent of 3D printing technology, the investigators are now in the planning stages of implementing a new clinical protocol to bring PSIOs to Johns Hopkins Hospital (JHH). A cleft orthodontist at an equipped center will remotely design these orthodontic molds, which will then be 3D printed using dental acrylic (the same material currently used in hand-fabricated orthodontic models) and given to patients in the investigators' clinic. As planning these devices for 3D printing can be done remotely in a fraction of the time it would take to create each one by hand, this change in clinical practice will eliminate the need for an in-person specialized craniofacial orthodontist on faculty where one does not exist.
This research study seeks to elucidate both the investigators' current standard of cleft practice and the benefits the investigators hope to see after implementing this change in clinical practice. The investigators expect that although the investigators will initially create each new mold after a weekly hospital visit with in-person measurements, the investigators ultimately aim to develop an algorithm to predict early growth and development of the newborn's facial skeleton and soft tissue. This will allow the fabrication of sequential pre-surgical orthopedic molding devices based of the infant's predicted facial growth, which can be delivered en bloc to the infants home, thereby eliminating the need for frequent visits to geographically inconvenient centers. After 4-5 months of using these devices, the bony cleft gap will be closed, the nose straightened, and the child be ready for the definitive cleft lip and nose repair in a single surgery. These devices will not only physically close the gap of the cleft lip deformity, but will also close the gap in access to the necessary specialists for the ideal management of cleft deformities across the country. With this technology, any cleft center can offer naso-alveolar molding to every child born with cleft lip and palate in the country.
- Being tested
- Cleft Lip/Nose Repair without PSIO, Presurgical Infant Orthopedic Therapy
- Keywords
- Cleft Lip
- Medical subject headings
- Cleft Lip, Congenital Abnormalities, Nose Deformities, Acquired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cleft Lip/Nose Repair without PSIOProcedure or surgery
Standard of care surgical repair of cleft lip/nose without PSIO.
Presurgical Infant Orthopedic TherapyProcedure or surgery
Standard of care surgical repair of cleft lip/nose with PSIO.
| Study group | Role | What they receive |
|---|---|---|
| Cleft Lip/Nose Repair without PSIO | Participants who will undergo cleft lip/nose repair prior to addition of PSIO as part of standard of care in Hopkins. Receives: Procedure: Cleft Lip/Nose Repair without PSIO | |
| Presurgical Infant Orthopedic Therapy | Participants who will undergo cleft lip/nose repair after addition of PSIO as part of standard of care in Hopkins. Receives: Procedure: Presurgical Infant Orthopedic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of cleft patients with an alveolar cleft of <5 mm at time of the first surgery
Percentage of cleft patients with an alveolar cleft of <5 mm at time of the first surgery will be assessed to determine the effect of 3D printed orthognathic pre-surgical molding devices on cleft care.
Measured: At the time of first surgery (3 months)
Cleft size at initial clinic presentation
Cleft size in millimeters (mm) at initial clinic presentation.
Measured: At the time of initial clinic visit up to 1 hour
Size of cleft at pre- and post-operative clinic visit
Size of cleft in millimeters at pre- and post-operative clinic visit
Measured: At pre- and post-operative clinic visit, up to 4 months
Secondary outcomes (4)
Rate of change in cleft size
The rate of change in cleft size (mm/week).
Measured: Weekly, up 8 weeks
Length of time to achieve a cleft <5 mm
Length of time in days to achieve a cleft <5 mm.
Measured: Up to 4 months
Aesthetic outcome following cleft surgical repair as assessed by the surgeon
Aesthetic outcome following cleft surgical repair wiil be assessed by the surgeon using a clinical judgment.
Measured: Post surgery, up to 4 months
Satisfaction with the 3-D printed pre-surgical orthopedic device as assessed by parents
Satisfaction with the 3-D printed pre-surgical orthopedic device will be assessed by a satisfaction questionnaire administered to parents.
Measured: Post surgery, up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start8 Jun 2020
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Why it stopped: no enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft LipStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Redett, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334590
- Sponsor's protocol ID
- IRB00176186
- Status last verified
- Aug 2023
- First submitted
- 2 Apr 2020
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Surgical Planning for the Fabrication of Sequential Naso-Alveolar Molding Appliances in the Treatment of Cleft Lip/Nose Deformities
- ClinicalTrials.gov ID
- NCT04334590
- Acronym / sponsor ID
- IRB00176186
- Keywords
- Cleft Lip
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 6 Apr 2020 (actual)
- 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.
There is a robust body of research suggesting that the use of pre-surgical orthopedic devices prior to definitive cleft lip/nose repair results in significant improvement of facial aesthetics with long term follow up. However, in recent surveys of the cleft centers in the US, only 30% of cleft centers offer PSIOs, and only 13% routinely report its use. Accordingly, thirty percent of centers utilize a two-stage cleft lip/nose repair in the centers' algorithm (1st: lip adhesion; 2nd: final lip repair). The major drawback to a two-stage cleft procedure is the administration of two general anesthetics to an infant before the age of one year. There is a growing amount of evidence that multiple anesthetic experiences before a certain age could affect brain development.
It is difficult to make inferences as to why clinicians are not utilizing surgical aids to decrease the size of the cleft width, but even when PSIO is offered, caregivers experience additional, potentially prohibitive challenges. In one study, caregivers traveled an average of 70 miles to visit the nearest cleft center offering pre-surgical orthopedic devices. As these devices are created by hand every 1-2 weeks after seeing the child in clinic, parents are required to travel to clinic multiple times per month. Not surprisingly, infants who were first-born and those who did not have other siblings were more likely to receive pre-surgical orthopedic treatment than infants who were residing with other siblings.
Given the benefits of PSIOs and the barriers both to healthcare systems and patients' families associated with PSIOs in its current form, a new form of pre-surgical clinical management is needed.
Objectives:
- Evaluate JHH's current clinical performance in addressing unilateral cleft lip and nasal deformity.
- Elucidate the difference in preoperative cleft size and in surgical management/outcomes for patients who received PSIOs through 3D-printed devices.
- Using the above maxillofacial growth data with and without PSIOs, the investigators aim to create an algorithm to predict maxillofacial growth for each individual patient to design pre-sequenced custom PSIO devices.
Detailed description
Approximately 7000 babies are born with a cleft lip and/or cleft palate in the United States per year. Globally, this defect is staggeringly common, with 100,000 new cases per year. This defect is due to a failure of normal fusion between facial structures, causing a full thickness gap of the upper lip involving skin, muscle, and other connective tissue. Due to aberrant insertion of the muscle underlying the lip as well as abnormal formation of deeper facial structures, the nose is also displaced inferiorly, laterally, and posteriorly. The wider the cleft, the more challenging the repair.
Current best practice in treating unilateral cleft lip and nose deformity involves presurgical infant orthopedics (PSIOs). PSIOs involves presurgically treating the deformity using custom orthodontics to gradually bring the two halves of the cleft together, reducing defect size and enabling complete repair with one surgery during early infancy. However, creation of these molds is time consuming and requires the expertise of a cleft orthodontist and weekly visits to the hospital for device advancement. As not all cleft centers have a specialized cleft orthodontist-including Johns Hopkins Hospital-many are unable to provide presurgical infant orthopedics. Weekly travel to cleft centers can also pose a significant temporal and financial burden to families, as the average patient is located over 60 miles from the nearest cleft center. In a recent survey of cleft centers in the United States, only 30% of these centers are able to provide presurgical orthopedic molding devices in treatment protocols. These centers therefore correct wide clefts with a staged, two-surgery approach. This approach is often less successful in both adequately aligning the gum and in repairing nasal defects, and usually requires intensive orthodontics and additional surgeries in adolescence. As the defect is not fully corrected in infancy, children are additionally subjected to the emotional and psychological difficulty and damage to self-esteem associated with the persistent defect.
With the advent of 3D printing technology, the investigators are now in the planning stages of implementing a new clinical protocol to bring PSIOs to Johns Hopkins Hospital (JHH). A cleft orthodontist at an equipped center will remotely design these orthodontic molds, which will then be 3D printed using dental acrylic (the same material currently used in hand-fabricated orthodontic models) and given to patients in the investigators' clinic. As planning these devices for 3D printing can be done remotely in a fraction of the time it would take to create each one by hand, this change in clinical practice will eliminate the need for an in-person specialized craniofacial orthodontist on faculty where one does not exist.
This research study seeks to elucidate both the investigators' current standard of cleft practice and the benefits the investigators hope to see after implementing this change in clinical practice. The investigators expect that although the investigators will initially create each new mold after a weekly hospital visit with in-person measurements, the investigators ultimately aim to develop an algorithm to predict early growth and development of the newborn's facial skeleton and soft tissue. This will allow the fabrication of sequential pre-surgical orthopedic molding devices based of the infant's predicted facial growth, which can be delivered en bloc to the infants home, thereby eliminating the need for frequent visits to geographically inconvenient centers. After 4-5 months of using these devices, the bony cleft gap will be closed, the nose straightened, and the child be ready for the definitive cleft lip and nose repair in a single surgery. These devices will not only physically close the gap of the cleft lip deformity, but will also close the gap in access to the necessary specialists for the ideal management of cleft deformities across the country. With this technology, any cleft center can offer naso-alveolar molding to every child born with cleft lip and palate in the country.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cleft Lip/Nose Repair without PSIO | – | Procedure: Cleft Lip/Nose Repair without PSIOParticipants who will undergo cleft lip/nose repair prior to addition of PSIO as part of standard of care in Hopkins. |
| Presurgical Infant Orthopedic Therapy | – | Procedure: Presurgical Infant Orthopedic TherapyParticipants who will undergo cleft lip/nose repair after addition of PSIO as part of standard of care in Hopkins. |
Who may qualify
- Ages
- 0 months to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns either born in Johns Hopkins or presenting to clinic with a cleft lip between 0-1 months of life.
Key inclusion criteria (1 listed)
- All newborns either born in Johns Hopkins or presenting to clinic with a cleft lip between 0-1 months of life
Key exclusion criteria (1 listed)
- Patients older than one month of age at presentation
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 |
|---|---|---|
| Cleft Lip/Nose Repair without PSIOStandard of care surgical repair of cleft lip/nose without PSIO. | Procedure or surgery | Cleft Lip/Nose Repair without PSIO |
| Presurgical Infant Orthopedic TherapyStandard of care surgical repair of cleft lip/nose with PSIO. | Procedure or surgery | Presurgical Infant Orthopedic Therapy |
Primary outcome
Percentage of cleft patients with an alveolar cleft of <5 mm at time of the first surgery
Time frame: At the time of first surgery (3 months)
Percentage of cleft patients with an alveolar cleft of <5 mm at time of the first surgery will be assessed to determine the effect of 3D printed orthognathic pre-surgical molding devices on cleft care.
Cleft size at initial clinic presentation
Time frame: At the time of initial clinic visit up to 1 hour
Cleft size in millimeters (mm) at initial clinic presentation.
Size of cleft at pre- and post-operative clinic visit
Time frame: At pre- and post-operative clinic visit, up to 4 months
Size of cleft in millimeters at pre- and post-operative clinic visit
4 secondary outcomes
Rate of change in cleft size
Time frame: Weekly, up 8 weeks
Length of time to achieve a cleft <5 mm
Time frame: Up to 4 months
Aesthetic outcome following cleft surgical repair as assessed by the surgeon
Time frame: Post surgery, up to 4 months
Satisfaction with the 3-D printed pre-surgical orthopedic device as assessed by parents
Time frame: Post surgery, up to 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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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.
Richard Redett principal investigator
Johns Hopkins University
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 Congenital Nose Malformation, run by Johns Hopkins University 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 21 Aug 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Percentage of cleft patients with an alveolar cleft of <5 mm at time of the first surgery (time frame: At the time of first surgery (3 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2023.