Cleft Lip and Cleft PalateNCT07814625
Improving the Outcomes of Nasoalveolar Molding in Complete Bilateral Cleft Lip and Palate Neonates Using a Modification in the Design of the Conventional Molding Appliance.
A study testing vomer molding appliance and conventional molding appliance in people with Cleft Lip and Cleft Palate and Cleft Lip Bilateral, run by Tanta University at 1 site in Egypt.
Trial summary
The goal of this clinical trial was to improve the outcome of using the nasoalveoalr molding appliances in patients with complete bilateral cleft lip and palate. The primary outcome was to compare VMA and CMA regarding the three-dimensional change in the maxillary arch: anteroposterior, transverse, and vertical. Read more about this study
- Who is it for?
- Ages 1 day to 15 days
- Conditions the study is for
- Cleft Lip and Cleft Palate, Cleft Lip Bilateral, Complete Bilateral Cleft Lip and Palate
- What is being tested?
- vomer molding appliance and conventional molding appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Feb 2026
- 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 15 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Non-syndromic complete bilateral cleft lip and palate neonate.
- The deviation of the premaxilla is to the right side for ease of comparison.
Who cannot join
- Syndromic cases.
- Patients who received former interventions.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry -Tanta university
Tanta, Gharbia Governorate, 11311
About this study
Official title: Improving the Outcomes of Nasoalveolar Molding in Complete Bilateral Cleft Lip and Palate Neonates: Randomized Clinical Trial
The goal of this clinical trial was to improve the outcome of using the nasoalveoalr molding appliances in patients with complete bilateral cleft lip and palate.
The primary outcome was to compare VMA and CMA regarding the three-dimensional change in the maxillary arch: anteroposterior, transverse, and vertical. The changes in the maxillary arch were assessed via the digital models acquired at two time intervals: before NAM therapy and 4 months after the start of either intervention modality (VMA and CMA).
Participants were divided into two groups: the vomer molding appliance group and the conventional molding appliance group , the appliances were delivered , followed up for 4 months till primary cheiloplasty and the results were assessd before the surgert.
Read the detailed description
Before the commencement of NAM therapy, an impression of the infant's maxillary arch was taken using a additional silicone elastomeric impression material (regular viscosity). The procedure involved a customized acrylic tray and was conducted with the infant fully awake, positioned head facing the clinician, and securely held by an assistant in the clinic. The impression should record accurately all the maxillary arch extending to the labial vestibule anteriorly and to the maxillary tuberosity posteriorly and registering all the undercuts around the vomer. The impression poured in hard stone , wax pattern made on the master cast , flasking and curing with clear heat cure acrylic resin and finishing and polishing before delivering to the baby.
- Being tested
- vomer molding appliance, conventional molding appliance
- Keywords
- vomer molding appliance, bilateral cleft lip and palate
- Medical subject headings
- Cleft Lip, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vomer molding applianceDevice
All the infants in the VMA group received clear heat cured acrylic resin appliance. Firstly, an impression was taken using additional rubber base (Zhirmach-Germany) and registering all undercuts carefully then impression was poured using Type III stone maintaining the desired undercuts around the vomer. Wax pattern of the appliance was made, with two retentive arms flasking, packing with clear heat cured acrylic resin then curing, finishing and polishing.
conventional molding applianceDevice
After taking the impression and pouring the cast, it was prepared by blocking out all undercut areas with stone or plaster. An intraoral molding plate was then fabricated on the prepared working model using clear heat-cured acrylic resin. Retention of the appliance in both groups was achieved in the same manner; medium elastic bands (3/16 inch, 4.5 oz) were looped around each button and secured to the cheeks with surgical tape. The elastic bands were stretched to twice their passive diameter to ensure proper force activation and retention. Protective tape was applied to the cheeks to minimize tissue irritation from the surgical tapes, and further emollient creams were prescribed when needed. Additionally, horizontal lip tape was applied across the base of the nose, extending from one cheek to the other, starting from the first visit with the same-sized elastic band in the middle.
| Study group | Role | What they receive |
|---|---|---|
| Vomer molding appliance (VMA) group A | Active comparator | All the infants in the VMA group received a clear heat-cured acrylic resin appliance. Firstly, an impression was taken using an additional rubber base and registering all undercuts carefully, then the impression was poured using Type III stone, maintaining the desired undercuts around the vomer. A wax pattern of the appliance was made, with two retentive arms flasking, packing with clear heat-cured acrylic resin, then curing, finishing, and polishing. Receives: Device: vomer molding appliance |
| Conventional molding appliance group B | Active comparator | After taking the impression and pouring the cast, it was prepared by blocking out all undercut areas with stone or plaster. An intraoral molding plate was then fabricated on the prepared working model using clear heat-cured acrylic resin. Retention of the appliance in both groups was achieved in the same manner; medium elastic bands (3/16 inch, 4.5 oz) were looped around each button and secured to the cheeks with surgical tape. The elastic bands were stretched to twice their passive diameter to ensure proper force activation and retention. Protective tape was applied to the cheeks to minimize tissue irritation from the surgical tapes, and further emollient creams were prescribed when needed. Additionally, horizontal lip tape was applied across the base of the nose, extending from one cheek to the other, starting from the first visit with the same-sized elastic band in the middle. Receives: Device: conventional molding appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare VMA and CMA regarding the three-dimensional change in the maxillary arch: anteroposterior, transverse, and vertical.
The changes in the maxillary arch were assessed via the digital models acquired at two time intervals: before NAM therapy and 4 months after the start of either intervention modality (VMA and CMA).
Measured: from enrollment till 4 months of age
Compare VMA and CMA regarding the three-dimensional change in the maxillary arch: anteroposterior & transverse.
The changes in the maxillary arch were assessed via the digital models acquired at two time intervals: before NAM therapy and 4 months after the start of either intervention modality (VMA and CMA).
Measured: from enrollment to the end of treatment before primary chieloplasty (about 4 months of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Dec 2024
- Primary completion1 Jan 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and Cleft PalateStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 20 BCLP infants were randomly divided into, group 1 (n = 10) received vomer molding appliance (VMA), and Group 2 (n = 10) underwent conventional molding appliance (CMA). The work was performed at the outpatient clinic in prosthodontics department , Faculty of dentistry-Tanta University. The inclusion criteria included a non-syndromic, complete bilateral cleft lip and palate neonate, and the deviation of the premaxilla is to the right side for ease of comparison. In the VMA group, all infants received the appliance with unblocked undercuts surrounding the vomer. In the CMA, Grayson's NAM technique was followed, where the undercuts were blocked, and a soft liner was used to mold the alveolus. The nasal stents were used in both groups in the same manner to mold the deformed nasal cartilages. Four main variables in the digital maxillary models were analyzed at T1 (pre-NAM therapy) and T2 (post-NAM therapy) using 3D software.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Mohamed Abdallah, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814625
- Sponsor's protocol ID
- R-RP 10-24-3148
- Status last verified
- Oct 2024
- First submitted
- 26 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the results and clinical findings
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Outcomes of Nasoalveolar Molding in Complete Bilateral Cleft Lip and Palate Neonates: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07814625
- Acronym / sponsor ID
- R-RP 10-24-3148
- Keywords
- vomer molding appliance, bilateral cleft lip and palate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 11 Sep 2026 (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.
The goal of this clinical trial was to improve the outcome of using the nasoalveoalr molding appliances in patients with complete bilateral cleft lip and palate.
The primary outcome was to compare VMA and CMA regarding the three-dimensional change in the maxillary arch: anteroposterior, transverse, and vertical. The changes in the maxillary arch were assessed via the digital models acquired at two time intervals: before NAM therapy and 4 months after the start of either intervention modality (VMA and CMA).
Participants were divided into two groups: the vomer molding appliance group and the conventional molding appliance group , the appliances were delivered , followed up for 4 months till primary cheiloplasty and the results were assessd before the surgert.
Detailed description
Before the commencement of NAM therapy, an impression of the infant's maxillary arch was taken using a additional silicone elastomeric impression material (regular viscosity). The procedure involved a customized acrylic tray and was conducted with the infant fully awake, positioned head facing the clinician, and securely held by an assistant in the clinic. The impression should record accurately all the maxillary arch extending to the labial vestibule anteriorly and to the maxillary tuberosity posteriorly and registering all the undercuts around the vomer. The impression poured in hard stone , wax pattern made on the master cast , flasking and curing with clear heat cure acrylic resin and finishing and polishing before delivering to the baby.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 20 BCLP infants were randomly divided into, group 1 (n = 10) received vomer molding appliance (VMA), and Group 2 (n = 10) underwent conventional molding appliance (CMA). The work was performed at the outpatient clinic in prosthodontics department , Faculty of dentistry-Tanta University. The inclusion criteria included a non-syndromic, complete bilateral cleft lip and palate neonate, and the deviation of the premaxilla is to the right side for ease of comparison. In the VMA group, all infants received the appliance with unblocked undercuts surrounding the vomer. In the CMA, Grayson's NAM technique was followed, where the undercuts were blocked, and a soft liner was used to mold the alveolus. The nasal stents were used in both groups in the same manner to mold the deformed nasal cartilages. Four main variables in the digital maxillary models were analyzed at T1 (pre-NAM therapy) and T2 (post-NAM therapy) using 3D software.
| Arm | Type | Receives |
|---|---|---|
| Vomer molding appliance (VMA) group A | Active comparator | Device: vomer molding applianceAll the infants in the VMA group received a clear heat-cured acrylic resin appliance. Firstly, an impression was taken using an additional rubber base and registering all undercuts carefully, then the impression was poured using Type III stone, maintaining the desired undercuts around the vomer. A wax pattern of the appliance was made, with two retentive arms flasking, packing with clear heat-cured acrylic resin, then curing, finishing, and polishing. |
| Conventional molding appliance group B | Active comparator | Device: conventional molding applianceAfter taking the impression and pouring the cast, it was prepared by blocking out all undercut areas with stone or plaster. An intraoral molding plate was then fabricated on the prepared working model using clear heat-cured acrylic resin. Retention of the appliance in both groups was achieved in the same manner; medium elastic bands (3/16 inch, 4.5 oz) were looped around each button and secured to the cheeks with surgical tape. The elastic bands were stretched to twice their passive diameter to ensure proper force activation and retention. Protective tape was applied to the cheeks to minimize tissue irritation from the surgical tapes, and further emollient creams were prescribed when needed. Additionally, horizontal lip tape was applied across the base of the nose, extending from one cheek to the other, starting from the first visit with the same-sized elastic band in the middle. |
Who may qualify
- Ages
- 1 day to 15 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Non-syndromic complete bilateral cleft lip and palate neonate.
- The deviation of the premaxilla is to the right side for ease of comparison.
Key exclusion criteria (2 listed)
- Syndromic cases.
- Patients who received former interventions.
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 |
|---|---|---|
| vomer molding applianceAll the infants in the VMA group received clear heat cured acrylic resin appliance. Firstly, an impression was taken using additional rubber base (Zhirmach-Germany) and registering all undercuts carefully then impression was poured using Type III stone maintaining the desired undercuts around the vomer. Wax pattern of the appliance was made, with two retentive arms flasking, packing with clear heat cured acrylic resin then curing, finishing and polishing. | Device | Vomer molding appliance (VMA) group A |
| conventional molding applianceAfter taking the impression and pouring the cast, it was prepared by blocking out all undercut areas with stone or plaster. An intraoral molding plate was then fabricated on the prepared working model using clear heat-cured acrylic resin. Retention of the appliance in both groups was achieved in the same manner; medium elastic bands (3/16 inch, 4.5 oz) were looped around each button and secured to the cheeks with surgical tape. The elastic bands were stretched to twice their passive diameter to ensure proper force activation and retention. Protective tape was applied to the cheeks to minimize tissue irritation from the surgical tapes, and further emollient creams were prescribed when needed. Additionally, horizontal lip tape was applied across the base of the nose, extending from one cheek to the other, starting from the first visit with the same-sized elastic band in the middle. | Device | Conventional molding appliance group B |
Primary outcome
Compare VMA and CMA regarding the three-dimensional change in the maxillary arch: anteroposterior, transverse, and vertical.
Time frame: from enrollment till 4 months of age
The changes in the maxillary arch were assessed via the digital models acquired at two time intervals: before NAM therapy and 4 months after the start of either intervention modality (VMA and CMA).
Compare VMA and CMA regarding the three-dimensional change in the maxillary arch: anteroposterior & transverse.
Time frame: from enrollment to the end of treatment before primary chieloplasty (about 4 months of age)
The changes in the maxillary arch were assessed via the digital models acquired at two time intervals: before NAM therapy and 4 months after the start of either intervention modality (VMA and CMA).
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 11 Sep 2026.
- Individual participant dataSharing planned: Yes. the results and clinical findings
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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.
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 vomer molding appliance and conventional molding appliance in people with Cleft Lip and Cleft Palate and Cleft Lip Bilateral, run by Tanta 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 2 inclusion and 2 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 11 Sep 2026. 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?
Compare VMA and CMA regarding the three-dimensional change in the maxillary arch: anteroposterior, transverse, and vertical. (time frame: from enrollment till 4 months of age). The study lists 2 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 11 Sep 2026.