An interventional study of vomer molding appliance and conventional molding appliance in Cleft Lip and Cleft Palate, Cleft Lip Bilateral and Complete Bilateral Cleft Lip and Palate, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 1 Day to 15 Days. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Tanta University · Not applicable, Interventional, and Supportive care
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.
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.
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's enrollment of 20 is below the median of 30 across 116 interventional studies indexed under Cleft Lip.
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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.
Device: vomer molding appliance
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.
Device: conventional molding appliance
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.
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.
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).
Time frame: 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).
Time frame: from enrollment to the end of treatment before primary chieloplasty (about 4 months of age)
Plan to share: Yes — the results and clinical findings
Supporting information: Study protocol, Informed consent form
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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