Cleft Lip and PalateNCT03011489
Parent's Satisfaction and Evaluation of Postsurgical Outcomes in Unilateral Cleft Lip / Palate Newly Born Infants With / Without Vacuum Formed Nasoalveolar Molding Aligners : A Controlled Clinical Trial
A study testing Vacuum formed aligners in people with Cleft Lip and Palate, run by Cairo University.
Trial summary
Newborns with unilateral cleft lip/ palate will be treated pre-surgically by Vacuum formed aligners in order to evaluate its effect on Nasoalveolar complex. Read more about this study
- Who is it for?
- Ages 1 week to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Vacuum formed aligners
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2017
- Phase
- Interventional
- 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 1 week to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Non-syndromic Infants with complete unilateral cleft lip and palate
- Infants less than 3 months of age
- Males and females.
- Infants with displaced alveolus
- Patients whose parents provided written consent for the study.
Who cannot join
- Patients above 3 months of age
- Syndromic, malnourished and systemically ill infants.
- Patients with bilateral cleft lip and palate.
- Incomplete Cleft lip.
- Medically compromised patients
- Patient's/guardians who will be unwilling to go through the PNAM therapy
Trial locations and contacts
No sites are listed yet.
About this study
Newborns with unilateral cleft lip/ palate will be treated pre-surgically by Vacuum formed aligners in order to evaluate its effect on Nasoalveolar complex.
Read the detailed description
newborns with unilateral cleft lip/ palate will be allocated into two groups: treatment group will receive Vacuum formed aligners while control group will not receive Vacuum formed aligners.
the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, standardized photographs for measurement of nasal changes and interlabial gap outcome and digital maxillary models for the maxillary dimension change outcome.
- Conditions
- Cleft Lip and Palate
- Being tested
- Vacuum formed aligners
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum formed alignersDevice
Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is a modified step in Figueroa's technique.
| Study group | Role | What they receive |
|---|---|---|
| Vacuum formed aligners group | Experimental | This group will receive Vacuum formed aligners in addition to taping for 3 Months with follow-up every 1-2 weeks Receives: Device: Vacuum formed aligners |
| control group | No intervention | This group will not receive any treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents' satisfaction
It will be measured by questionnaire
Measured: 3 months
Secondary outcomes (3)
Changes in Nasal morphology( Height, width, angulation of columella
It will be measured in mm by Standardized Digital photographs
Measured: 3 months
Changes in Interlabial gab
It will be measured in mm by Standardized Digital photographs
Measured: 3 months
Changes in Maxillary arch dimension
It will be measured in mm by Digital models
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khadega Ali Al Khateeb, Cairo University
- Investigators
- Fatma Abdu Abdelsayed, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011489
- Sponsor's protocol ID
- UCLP_Vacuum
- Status last verified
- Apr 2017
- First submitted
- 4 Jan 2017
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent's Satisfaction and Evaluation of Postsurgical Outcomes in Unilateral Cleft Lip / Palate Newly Born Infants With / Without Vacuum Formed Nasoalveolar Molding Aligners : A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03011489
- Acronym / sponsor ID
- UCLP_Vacuum
- Conditions
- Cleft Lip and Palate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 5 Jan 2017 (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.
Newborns with unilateral cleft lip/ palate will be treated pre-surgically by Vacuum formed aligners in order to evaluate its effect on Nasoalveolar complex.
Detailed description
newborns with unilateral cleft lip/ palate will be allocated into two groups: treatment group will receive Vacuum formed aligners while control group will not receive Vacuum formed aligners.
the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, standardized photographs for measurement of nasal changes and interlabial gap outcome and digital maxillary models for the maxillary dimension change outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vacuum formed aligners group | Experimental | Device: Vacuum formed alignersThis group will receive Vacuum formed aligners in addition to taping for 3 Months with follow-up every 1-2 weeks |
| control group | No intervention | –This group will not receive any treatment |
Who may qualify
- Ages
- 1 week to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Non-syndromic Infants with complete unilateral cleft lip and palate
- Infants less than 3 months of age
- Males and females.
- Infants with displaced alveolus
- Patients whose parents provided written consent for the study.
Key exclusion criteria (6 listed)
- Patients above 3 months of age
- Syndromic, malnourished and systemically ill infants.
- Patients with bilateral cleft lip and palate.
- Incomplete Cleft lip.
- Medically compromised patients
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 |
|---|---|---|
| Vacuum formed alignersInfants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is a modified step in Figueroa's technique. | Device | Vacuum formed aligners group |
Primary outcome
Parents' satisfaction
Time frame: 3 months
It will be measured by questionnaire
3 secondary outcomes
Changes in Nasal morphology( Height, width, angulation of columella
Time frame: 3 months
Changes in Interlabial gab
Time frame: 3 months
Changes in Maxillary arch dimension
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Cleft Lip and Palate
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruiting
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
RecruitingObservational study
Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate
Cleft Lip and Palate, Cleft Palate Children
Not yet recruitingPhase 3
Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair
Cleft Lip Palate
Enrolling by invitation
Speech Intervention Frameworks in Cantonese-speaking Children and Adolescences With Cleft Palate +/- Lip
Cleft Palate +/- Lip
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.
Fatma Abdu Abdelsayed, professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum formed aligners in people with Cleft Lip and Palate, run by Cairo University.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khadega Ali Al Khateeb, Master (00201100739869, khadejaalkhateeb@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parents' satisfaction (time frame: 3 months). 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 25 Apr 2017.