Cleft Lip and PalateNCT04966572
Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Grayson Acrylic Formed Nasoalveolar Molding Appliances.
A study testing Presurgical vacuum formed nasoalveolar molding aligners and Conventional Grayson acrylic formed nasoalveolar molding appliances in people with Cleft Lip and Palate and Bilateral Cleft Lip/Palate, run by Cairo University at 1 site in Egypt.
Trial summary
Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either presurgical vacuum-formed nasoalveolar molding aligners VF (NAM) or conventional Grayson acrylic formed nasoalveolar molding appliances in order to evaluate their effect on the maxillary arch. Read more about this study
- Who is it for?
- Ages 1 day to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate, Bilateral Cleft Lip/Palate
- What is being tested?
- Presurgical vacuum formed nasoalveolar molding aligners and Conventional Grayson acrylic formed nasoalveolar molding appliances
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 30 Mar 2022
- 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 day to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Non-syndromic Infants with complete BCLP infants
- Infants less than 1 month of age
- Males and females.
- Infants with displaced premaxilla
- Patients whose parents provided written consent for the study.
Who cannot join
- Patients above 1 month of age
- Syndromic and systemically ill infants.
- Patients with unilateral 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
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Mai Aboul Fotouh, lecturer, 00201001884499, mai.aboulfotouh@dentistry.cu.edu.eg
Mohamed Abd El-Ghafour, lecturer, 00201007433288, m.abdelghafour@dentistry.cu.edu.eg
About this study
Official title: Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Conventional Grayson Acrylic Formed Nasoalveolar Molding Appliances: A Randomized Clinical Trial
Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either presurgical vacuum-formed nasoalveolar molding aligners VF (NAM) or conventional Grayson acrylic formed nasoalveolar molding appliances in order to evaluate their effect on the maxillary arch.
Read the detailed description
The aim of this trial is to evaluate and compare the short-term effect of VF (NAM) aligners with conventional Grayson appliances at 2 stages T1 (Before NAM therapy), and T2 (After NAM therapy) as regards maxillary arch changes.
Newborns with Bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive presurgical vacuum-formed nasoalveolar molding aligners while the second group will receive conventional Grayson acrylic formed nasoalveolar molding appliances. The follow-up period will be 4-6 months till surgical lip closure. The changes in the maxillary arch will be assessed by digital maxillary models.
- Conditions
- Cleft Lip and Palate, Bilateral Cleft Lip/Palate
- Being tested
- Presurgical vacuum formed nasoalveolar molding aligners, Conventional Grayson acrylic formed nasoalveolar molding appliances
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presurgical vacuum formed nasoalveolar molding alignersDevice
at first visit, the infants will receive this appliance which is a maxillary vacuum plate incorporated with palatal screw, the infant's parents will be instructed to activate the screw and apply horizontal tap which will be placed at the base of nose in order to approximate lip segments and to change tape daily. After that, The infants will be recalled one week after the first visit to add the nasal stents into the appliance.
Conventional Grayson acrylic formed nasoalveolar molding appliancesDevice
at first visit, the infants will receive this appliance which is a maxillary acrylic plate without adding taping, the infants will be recalled bi weekly for activating the appliance.
When the cleft alveolar gap is reduced to 6mm or less, a pair of nasal stents will be added to mold the nasal cartilage. the infants will be followed up for 4-6 months.
| Study group | Role | What they receive |
|---|---|---|
| Presurgical vacuum formed nasoalveolar molding aligners group | Experimental | In this group, all patients will receive 1-2 VF-NAM aligners incorporated with palatal screw in addition to taping from day 1 for 4-6 Months with follow-up every 3 weeks Receives: Device: Presurgical vacuum formed nasoalveolar molding aligners |
| conventional Grayson acrylic formed nasoalveolar molding appliances group | Experimental | This group will receive conventional Grayson acrylic formed nasoalveolar molding appliances without taping except some cases, with follow up every week for activation. Receives: Device: Conventional Grayson acrylic formed nasoalveolar molding appliances |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the maxillary arch
they will be measured in mm by digital models
Measured: T1 and T2 (4- 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Mar 2021
- Primary completion1 Sep 2021 (estimated)
- Study completion30 Mar 2022 (estimated)
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
- 24 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
- NCT04966572
- Sponsor's protocol ID
- BCLP_ Grayson_ vacuum
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Khateeb KA, Aboulfotouh MH, Abdelsayed F, Mohamed W, Abd-El-Ghafour M. Three-dimensional assessment of maxillary arch changes in infants with bilateral cleft lip and palate using vacuum-formed nasoalveolar molding with active screw versus conventional nasoalveolar molding appliances: a randomized clinical trial. BMC Oral Health. 2025 Aug 19;25(1):1339. doi: 10.1186/s12903-025-06607-w.
PubMed 40830787
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Conventional Grayson Acrylic Formed Nasoalveolar Molding Appliances: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04966572
- Acronym / sponsor ID
- BCLP_ Grayson_ vacuum
- Conditions
- Cleft Lip and Palate, Bilateral Cleft Lip/Palate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 19 Jul 2021 (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.
Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either presurgical vacuum-formed nasoalveolar molding aligners VF (NAM) or conventional Grayson acrylic formed nasoalveolar molding appliances in order to evaluate their effect on the maxillary arch.
Detailed description
The aim of this trial is to evaluate and compare the short-term effect of VF (NAM) aligners with conventional Grayson appliances at 2 stages T1 (Before NAM therapy), and T2 (After NAM therapy) as regards maxillary arch changes.
Newborns with Bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive presurgical vacuum-formed nasoalveolar molding aligners while the second group will receive conventional Grayson acrylic formed nasoalveolar molding appliances. The follow-up period will be 4-6 months till surgical lip closure. The changes in the maxillary arch will be assessed by digital maxillary models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Presurgical vacuum formed nasoalveolar molding aligners group | Experimental | Device: Presurgical vacuum formed nasoalveolar molding alignersIn this group, all patients will receive 1-2 VF-NAM aligners incorporated with palatal screw in addition to taping from day 1 for 4-6 Months with follow-up every 3 weeks |
| conventional Grayson acrylic formed nasoalveolar molding appliances group | Experimental | Device: Conventional Grayson acrylic formed nasoalveolar molding appliancesThis group will receive conventional Grayson acrylic formed nasoalveolar molding appliances without taping except some cases, with follow up every week for activation. |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Non-syndromic Infants with complete BCLP infants
- Infants less than 1 month of age
- Males and females.
- Infants with displaced premaxilla
- Patients whose parents provided written consent for the study.
Key exclusion criteria (6 listed)
- Patients above 1 month of age
- Syndromic and systemically ill infants.
- Patients with unilateral 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 |
|---|---|---|
| Presurgical vacuum formed nasoalveolar molding alignersat first visit, the infants will receive this appliance which is a maxillary vacuum plate incorporated with palatal screw, the infant's parents will be instructed to activate the screw and apply horizontal tap which will be placed at the base of nose in order to approximate lip segments and to change tape daily. After that, The infants will be recalled one week after the first visit to add the nasal stents into the appliance. | Device | Presurgical vacuum formed nasoalveolar molding aligners group |
| Conventional Grayson acrylic formed nasoalveolar molding appliancesat first visit, the infants will receive this appliance which is a maxillary acrylic plate without adding taping, the infants will be recalled bi weekly for activating the appliance. When the cleft alveolar gap is reduced to 6mm or less, a pair of nasal stents will be added to mold the nasal cartilage. the infants will be followed up for 4-6 months. | Device | conventional Grayson acrylic formed nasoalveolar molding appliances group |
Primary outcome
Changes in the maxillary arch
Time frame: T1 and T2 (4- 6 months)
they will be measured in mm by digital models
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Derived from this study: PubMed 40830787Al-Khateeb KA, Aboulfotouh MH, Abdelsayed F, Mohamed W, Abd-El-Ghafour M. Three-dimensional assessment of maxillary arch changes in infants with bilateral cleft lip and palate using vacuum-formed nasoalveolar molding with active screw versus conventional nasoalveolar molding appliances: a randomized clinical trial. BMC Oral Health. 2025 Aug 19;25(1):1339. doi: 10.1186/s12903-025-06607-w.
- 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.
Fatma Abdu Abdelsayed, Professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Presurgical vacuum formed nasoalveolar molding aligners and Conventional Grayson acrylic formed nasoalveolar molding appliances in people with Cleft Lip and Palate and Bilateral Cleft Lip/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 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 22 Jul 2021. 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?
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, PhD (00201100739869, khadejaalkhateeb@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the maxillary arch (time frame: T1 and T2 (4- 6 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 NCT04966572, 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 22 Jul 2021.