Cleft Lip and PalateNCT02845193
Effect of Novel Nasoalveolar Molding Techniques on Parents' Satisfaction and Short Term Treatment Outcomes in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial
A study testing Modified Nasoalveolar molding, Taping and CAD/NAM in people with Cleft Lip and Palate, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this trial is to figure out the efficiency of modified Grayson NAM on parents' satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. NAM might improve and facilitate the surgical procedure after lip closure. Read more about this study
- Who is it for?
- Ages 7 to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Modified Nasoalveolar molding, Taping and CAD/NAM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2016to Apr 2019
- 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 7 to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants with age range from 7 - 30 days.
- Unilateral complete cleft lip and alveolus.
- Presence of unilateral cleft palate.
- Medically free subjects.
- Both males and females.
Who cannot join
- Patients older than 30 days.
- Syndromic patients with other defects in addition to cleft lip and palate.
- Patients with bilateral cleft lip and palate.
- Incomplete Cleft lip.
- Medically compromised patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of A Novel (Modified Grayson) Technique for Nasoalveolar Molding and Taping on Parents' Satisfaction and Short Term Treatment Outcomes in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Controlled Trial
The aim of this trial is to figure out the efficiency of modified Grayson NAM on parents' satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. NAM might improve and facilitate the surgical procedure after lip closure. This might decrease the need of further interventions to improve esthetics and function of CLP patients. This trial will help the patients and practitioners in taking the decision of inclusion of NAM in the CLP treatment protocol as a mandatory step or skip a useless procedure with all of its burden.
Read the detailed description
In this randomized trial, 4 groups will be included. The first group will receive a modified nasoalveolar molding appliance in addition to taping. In the second group, the patient will receive the CAD/NAM. the third group is tape only, while the fourth group remain untreated. the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, photographs for nasal esthetics and interlabial gap outcome and maxillary models for the maxillary dimension change outcome.
- Conditions
- Cleft Lip and Palate
- Being tested
- Modified Nasoalveolar molding, Taping, CAD/NAM
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Nasoalveolar moldingDevice
Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is routine step in Grayson's nasoalveolar molding technique).
TapingDevice
Infants will receive a tape only on the upper lip segments to mold it to touch each other.
CAD/NAMDevice
computer aided design NAM
| Study group | Role | What they receive |
|---|---|---|
| Modified Nasoalveolar molding group | Experimental | This group will receive nasoalveolar molding appliance in addition to taping for 3 Months with follow-up every 2 weeks. Receives: Device: Modified Nasoalveolar molding |
| Taping group | Experimental | Tape will be used alone in this group on the upper lip segments for 3 months with follow-up every 2 weeks. Receives: Device: Taping |
| Control group | No intervention | This group will not receive any treatment. |
| CAD/NAM group | Experimental | Computer Aided Designed Nasoalveolar molding and 3D printed. Receives: Device: CAD/NAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents' satisfaction
It will be assessed using Questionnaire.
Measured: 3 months
Secondary outcomes (6)
Nasal Esthetics: a- Nostril height
It will be measured in mm by Digital ruler on the images using a software.
Measured: 3 months
Nasal Esthetics: b- Nostril width
It will be measured in mm by Digital ruler on the images using a software.
Measured: 3 months
Nasal Esthetics: c- Nasal sill height
It will be measured in mm by Digital ruler on the images using a software.
Measured: 3 months
Nasal Esthetics: d- Nostril area
It will be measured on the images in mm 2 (square) using a software measuring area.
Measured: 3 months
Interlabial gap
It will be measured in mm by Digital ruler on the images using a software.
Measured: 3 months
Maxillary Arch Dimension
It will be measured as distances in mm between landmarks identified on the dental models assessing the anterioposterior, transverse and vertical changes.
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 posted27 Jul 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abd El-Ghafour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845193
- Sponsor's protocol ID
- CEBD-2016-07-172
- Status last verified
- Jul 2019
- First submitted
- 19 Jul 2016
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Abd El-Ghafour M, Aboulhassan MA, El-Beialy AR, Fayed MMS, Eid FHK, Emara D, El-Gendi M. Does Presurgical Taping Change Nose and Lip Aesthetics in Infants with Unilateral Cleft Lip and Palate? A Randomized Controlled Trial. Plast Reconstr Surg. 2022 Dec 1;150(6):1300e-1313e. doi: 10.1097/PRS.0000000000009738. Epub 2022 Sep 20.
PubMed 36126199
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of A Novel (Modified Grayson) Technique for Nasoalveolar Molding and Taping on Parents' Satisfaction and Short Term Treatment Outcomes in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02845193
- Acronym / sponsor ID
- CEBD-2016-07-172
- Conditions
- Cleft Lip and Palate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 27 Jul 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.
The aim of this trial is to figure out the efficiency of modified Grayson NAM on parents' satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. NAM might improve and facilitate the surgical procedure after lip closure. This might decrease the need of further interventions to improve esthetics and function of CLP patients. This trial will help the patients and practitioners in taking the decision of inclusion of NAM in the CLP treatment protocol as a mandatory step or skip a useless procedure with all of its burden.
Detailed description
In this randomized trial, 4 groups will be included. The first group will receive a modified nasoalveolar molding appliance in addition to taping. In the second group, the patient will receive the CAD/NAM. the third group is tape only, while the fourth group remain untreated. the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, photographs for nasal esthetics and interlabial gap outcome and maxillary models for the maxillary dimension change outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Modified Nasoalveolar molding group | Experimental | Device: Modified Nasoalveolar moldingThis group will receive nasoalveolar molding appliance in addition to taping for 3 Months with follow-up every 2 weeks. |
| Taping group | Experimental | Device: TapingTape will be used alone in this group on the upper lip segments for 3 months with follow-up every 2 weeks. |
| Control group | No intervention | –This group will not receive any treatment. |
| CAD/NAM group | Experimental | Device: CAD/NAMComputer Aided Designed Nasoalveolar molding and 3D printed. |
Who may qualify
- Ages
- 7 to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants with age range from 7 - 30 days.
- Unilateral complete cleft lip and alveolus.
- Presence of unilateral cleft palate.
- Medically free subjects.
- Both males and females.
Key exclusion criteria (5 listed)
- Patients older than 30 days.
- Syndromic patients with other defects in addition to cleft lip and palate.
- 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 |
|---|---|---|
| Modified Nasoalveolar moldingInfants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is routine step in Grayson's nasoalveolar molding technique). | Device | Modified Nasoalveolar molding group |
| TapingInfants will receive a tape only on the upper lip segments to mold it to touch each other. | Device | Taping group |
| CAD/NAMcomputer aided design NAM | Device | CAD/NAM group |
Primary outcome
Parents' satisfaction
Time frame: 3 months
It will be assessed using Questionnaire.
6 secondary outcomes
Nasal Esthetics: a- Nostril height
Time frame: 3 months
Nasal Esthetics: b- Nostril width
Time frame: 3 months
Nasal Esthetics: c- Nasal sill height
Time frame: 3 months
Nasal Esthetics: d- Nostril area
Time frame: 3 months
Interlabial gap
Time frame: 3 months
Maxillary Arch Dimension
Time frame: 3 months
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 23 Jul 2019.
- Derived from this study: PubMed 36126199Abd El-Ghafour M, Aboulhassan MA, El-Beialy AR, Fayed MMS, Eid FHK, Emara D, El-Gendi M. Does Presurgical Taping Change Nose and Lip Aesthetics in Infants with Unilateral Cleft Lip and Palate? A Randomized Controlled Trial. Plast Reconstr Surg. 2022 Dec 1;150(6):1300e-1313e. doi: 10.1097/PRS.0000000000009738. Epub 2022 Sep 20.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Nasoalveolar molding, Taping and CAD/NAM in people with Cleft Lip and Palate, run by Cairo University at 1 site in Egypt.
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 5 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 23 Jul 2019. 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 Egypt. 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?
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?
On the ClinicalTrials.gov record for NCT02845193, which also lists 1 linked publication.
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 23 Jul 2019.