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Outcome Measures

Primary Outcomes (2)

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).
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).
from enrollment to the end of treatment before primary chieloplasty (about 4 months of age)

Study Arms (2)

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.

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.

Interventions

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.

Vomer molding appliance (VMA) group A

conventional molding applianceDevice

MeSH Terms

Conditions

Cleft LipCleft Palate

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesJaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal Abnormalities

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

PARTICIPANT, CARE PROVIDER

Masking Details

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.

Purpose

SUPPORTIVE CARE

Intervention Model

PARALLEL

Model Details: 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.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Lecturer

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.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Vomer molding appliance (VMA) group A

Conventional molding appliance group B

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Vomer molding appliance (VMA) group A

Conventional molding appliance group B

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations