Cleft Lip and Cleft Palate, Cleft Lip Bilateral, Complete Bilateral Cleft Lip and Palate
Conditions
Keywords
vomer molding appliance, bilateral cleft lip and palate
Brief 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. 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.
Interventions
DEVICEvomer 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.
DEVICEconventional 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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
For randomization the patients were allocated to groups by date of attendance to the clinic; the first to come was assigned to group 1, then the second to group 2, and so on (odd numbers to group 1 and even numbers to group 2), and this was done by the author, who is responsible for performing the clinical work. The parents/guardians didn't know which group they would be allocated to.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
1 Days to 15 Days
Healthy volunteers
No
Inclusion criteria
* Non-syndromic complete bilateral cleft lip and palate neonate. * The deviation of the premaxilla is to the right side for ease of comparison.
Exclusion criteria
* Syndromic cases. * Patients who received former interventions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare VMA and CMA regarding the three-dimensional change in the maxillary arch: anteroposterior, transverse, and vertical. | 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. | 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). |
Countries
Egypt
Outcome results
None listed