Trial Outcomes & Findings for DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants (NCT NCT04455035)
NCT ID: NCT04455035
Last Updated: 2024-12-30
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
initial time of examination with study team, time of surgery (3 months post intervention)
Results posted on
2024-12-30
Participant Flow
Participant milestones
| Measure |
Retrospective Group(Control)
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.
|
Prospective Group
Prospective Group: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
4
|
|
Overall Study
COMPLETED
|
20
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data for this measure were not collected.
Baseline characteristics by cohort
| Measure |
Retrospective Group(Control)
n=20 Participants
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.
|
Prospective Group
n=4 Participants
Prospective Group: 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.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=20 Participants
|
4 Participants
n=4 Participants
|
24 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
0 Participants
Data for this measure were not collected.
|
|
Sex: Female, Male
Male
|
—
|
—
|
0 Participants
Data for this measure were not collected.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
4 participants
n=4 Participants
|
24 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Retrospective Group(Control)
n=20 Participants
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.
|
Prospective Group
n=4 Participants
Prospective Group: 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.
|
|---|---|---|
|
Changes in Soft Tissue as Indicated by Width of the Cleft Lip Measured From Extraoral Clinical Photographs
|
0.601 pixels
Standard Deviation 0.236
|
0.435 pixels
Standard Deviation 0.111
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Retrospective Group(Control)
n=20 Participants
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.
|
Prospective Group
n=4 Participants
Prospective Group: 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.
|
|---|---|---|
|
Changes in Soft Tissue as Indicated by Columellar Angle Measured From Extraoral Clinical Photographs
|
54.93 degrees
Standard Deviation 5.124
|
64.75 degrees
Standard Deviation 4.991
|
PRIMARY outcome
Timeframe: initial time of examination with study team, time of surgery (3 months post intervention)Population: Data was not collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: initial time of examination with study team, time of surgery (3 months post intervention)Population: Data was not collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: initial time of examination with study team, time of surgery (3 months post intervention)Population: Data for this outcome measure were not collected from the retrospective arm, as IRB approval was not requested to contact retrospective participants.
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.
Outcome measures
| Measure |
Retrospective Group(Control)
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.
|
Prospective Group
n=4 Participants
Prospective Group: 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.
|
|---|---|---|
|
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
improvement in quality of life
|
—
|
2.27 number of responses
Standard Deviation 0.83
|
|
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
no change in quality of life
|
—
|
1.68 number of responses
Standard Deviation 0.84
|
|
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
decrease in quality of life
|
—
|
0 number of responses
Standard Deviation 0
|
Adverse Events
Retrospective Group(Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prospective Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brett Chiquet, DDS, PhD, Associate Professor
The University of Texas Health Science Center at Houston
Phone: 7135008220
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place