Cleft Lip and PalateNCT04455035
DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants
A study testing Prospective Group in people with Cleft Lip and Palate, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to examine the effectiveness of the DynaCleft® system on soft tissues of infants with unilateral incomplete cleft lip and to assess influences on quality of life for infants who underwent DynaCleft® and that of their families. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Prospective Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2020to 6 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Retrospective Group:
- Unilateral cleft lip with or without cleft palate
- Patients of a single surgeon (Matthew Greives, MD)
- Patients with complete photographs:
- After birth, first visit
- At cleft lip repair (3-4 months)
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- Post-operative cleft repair (about 1 year of age)
- Prospective Group:
- Patients with incomplete unilateral cleft lip with or without cleft palate
- Patients of any surgeon
Who cannot join
- Retrospective Group:
- Bilateral cleft lip or complete unilateral cleft lip
- Patients operated on by other primary surgeons
- Patients with incomplete photo records will be evaluated to determine if the patient should be excluded
- Prospective Group:
- Patients with bilateral cleft lip or complete unilateral cleft lip
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- Patients whose parents refuse to consent to inclusion
- Patients with tape allergies to the adhesive of the DynaCleft®
- Patients with syndromic craniofacial conditions or Tessier type facial clefts
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to examine the effectiveness of the DynaCleft® system on soft tissues of infants with unilateral incomplete cleft lip and to assess influences on quality of life for infants who underwent DynaCleft® and that of their families.
- Conditions
- Cleft Lip and Palate
- Being tested
- Comparator: Retrospective Group(Control), Prospective Group
- Keywords
- Dynacleft
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: Retrospective Group(Control)Other
The control group for this study will be obtained from a retrospective chart review of electronic health records of patients with incomplete cleft lip who underwent surgery without any presurgical interventions.
Prospective GroupDevice
The study population for the prospective aspect will include recruited newborns with untreated unilateral incomplete cleft lip.
DynaCleft® + Nasal Elevator therapy will be discussed with parent(s) as a presurgical orthopedic option while awaiting primary cleft lip surgical repair that typically occurs between the ages of 3 to 6 months.Study duration will be up to three months of presurgical intervention.Photographs are to be taken at initial visit prior to presurgical intervention and later at completion of the DynaCleft® therapy immediately prior to lip surgery. Angles to be pictured are to include the standard anterior-posterior, profile, and worms-eye view.
Linear measurements will be obtained with a ruler and registered in millimeters. A goniometer will be used to measure angles.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Group(Control) | Active comparator | Not described Receives: Other: Comparator: Retrospective Group(Control) |
| Prospective Group | Experimental | Not described Receives: Device: Prospective Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Soft Tissue as Indicated by Width of the Cleft Lip Measured From Extraoral Clinical Photographs
Width of the cleft lip was measured from extraoral clinical photographs. Data reported is width of cleft lip at 3 months minus width of cleft lip at time of initial examination.
Measured: initial time of examination with study team, time of surgery (3 months post intervention)
Changes in Soft Tissue as Indicated by Columellar Angle Measured From Extraoral Clinical Photographs
Columellar angle was measured from extraoral clinical photographs. Data reported is columellar angle at 3 months minus columellar angle at time of initial examination.
Measured: initial time of examination with study team, time of surgery (3 months post intervention)
Changes in Soft Tissue as Indicated by Nostril Height Measured From Extraoral Clinical Photographs
Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome.
Measured: initial time of examination with study team, time of surgery (3 months post intervention)
Changes in Soft Tissue as Indicated by Nostril Width Measured From Extraoral Clinical Photographs
Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome.
Measured: initial time of examination with study team, time of surgery (3 months post intervention)
Secondary outcomes (1)
Average Number of Responses Indicating Improvement, no Change, or Decrease in Quality of Life as Assessed by the Infant and New Parent Quality of Life Questionnaire
The Infant and New Parent Quality of Life questionnaire consists of 22 questions related to quality of life. For each question, it was determined whether the response at 3 months indicated an improvement, no change, or a decrease in quality of life relative to the response at the time of initial examination. The average number with an improvement in quality of life (averaged over all 22 questions), the average number who had no change in quality of life (averaged over all 22 questions), and the average number who had a decrease in quality of life (averaged over all 22 questions) are reported.
Measured: initial time of examination with study team, time of surgery (3 months post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start21 Sep 2020
- Primary completion6 Apr 2021
- Study completion6 Apr 2021
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett Thomas Chiquet, The University of Texas Health Science Center, Houston
- Investigators
- Brett T Chiquet, DDS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455035
- Sponsor's protocol ID
- HSC-DB-20-0311
- Status last verified
- Dec 2024
- First submitted
- 26 Jun 2020
- Last updated
- 30 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants
- ClinicalTrials.gov ID
- NCT04455035
- Acronym / sponsor ID
- HSC-DB-20-0311
- Conditions
- Cleft Lip and Palate
- Keywords
- Dynacleft
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 6 Apr 2021 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Posted 30 Dec 2024
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 examine the effectiveness of the DynaCleft® system on soft tissues of infants with unilateral incomplete cleft lip and to assess influences on quality of life for infants who underwent DynaCleft® and that of their families.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Group(Control) | Active comparator | Other: Comparator: Retrospective Group(Control) |
| Prospective Group | Experimental | Device: Prospective Group |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Unilateral cleft lip with or without cleft palate
- Patients of a single surgeon (Matthew Greives, MD)
- Patients with complete photographs:
- Patients with incomplete unilateral cleft lip with or without cleft palate
- Patients of any surgeon
Key exclusion criteria (9 listed)
- Bilateral cleft lip or complete unilateral cleft lip
- Patients operated on by other primary surgeons
- Patients with incomplete photo records will be evaluated to determine if the patient should be excluded
- Patients with bilateral cleft lip or complete unilateral cleft lip
- Patients whose parents refuse to consent to inclusion
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 |
|---|---|---|
| Comparator: Retrospective Group(Control)The control group for this study will be obtained from a retrospective chart review of electronic health records of patients with incomplete cleft lip who underwent surgery without any presurgical interventions. | Other | Retrospective Group(Control) |
| Prospective GroupThe study population for the prospective aspect will include recruited newborns with untreated unilateral incomplete cleft lip. DynaCleft® + Nasal Elevator therapy will be discussed with parent(s) as a presurgical orthopedic option while awaiting primary cleft lip surgical repair that typically occurs between the ages of 3 to 6 months.Study duration will be up to three months of presurgical intervention.Photographs are to be taken at initial visit prior to presurgical intervention and later at completion of the DynaCleft® therapy immediately prior to lip surgery. Angles to be pictured are to include the standard anterior-posterior, profile, and worms-eye view. Linear measurements will be obtained with a ruler and registered in millimeters. A goniometer will be used to measure angles. | Device | Prospective Group |
Primary outcome
Changes in Soft Tissue as Indicated by Width of the Cleft Lip Measured From Extraoral Clinical Photographs
Time frame: initial time of examination with study team, time of surgery (3 months post intervention)
Width of the cleft lip was measured from extraoral clinical photographs. Data reported is width of cleft lip at 3 months minus width of cleft lip at time of initial examination.
Changes in Soft Tissue as Indicated by Columellar Angle Measured From Extraoral Clinical Photographs
Time frame: initial time of examination with study team, time of surgery (3 months post intervention)
Columellar angle was measured from extraoral clinical photographs. Data reported is columellar angle at 3 months minus columellar angle at time of initial examination.
Changes in Soft Tissue as Indicated by Nostril Height Measured From Extraoral Clinical Photographs
Time frame: initial time of examination with study team, time of surgery (3 months post intervention)
Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome.
Changes in Soft Tissue as Indicated by Nostril Width Measured From Extraoral Clinical Photographs
Time frame: initial time of examination with study team, time of surgery (3 months post intervention)
Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome. Data was not collected for this outcome.
1 secondary outcome
Average Number of Responses Indicating Improvement, no Change, or Decrease in Quality of Life as Assessed by the Infant and New Parent Quality of Life Questionnaire
Time frame: initial time of examination with study team, time of surgery (3 months post intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Brett T Chiquet, DDS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prospective Group in people with Cleft Lip and Palate, run by The University of Texas Health Science Center, Houston 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 10 inclusion and 9 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: stopped early, as of the sponsor's last update on 30 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 30 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Soft Tissue as Indicated by Width of the Cleft Lip Measured From Extraoral Clinical Photographs (time frame: initial time of examination with study team, time of surgery (3 months post intervention)). The study lists 4 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 30 Dec 2024.