Slow Expansion and Protraction in Cleft Lip and Palate Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2023-07-31

Brief Summary

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Evaluate the treatment outcome of slow maxillary expansion protocol on patients with cleft lip and palate, using a differential opening expander and face mask which will be measured and recorded by cone beam computed tomography (CBCT).

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Detailed Description

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Cleft lip and palate are among the most common deformities in children. Cleft patients are usually having orofacial problems as missing or unerupted permanent teeth, alveolar bone defect, speech difficulty. Patients with cleft lip and palate (CLP) commonly have maxillary arch constriction (maxillary hypoplasia) and Class III malocclusions due to deficient of maxillary growth. The upper jaw of patients with cleft palate will be expanded using maxillary Expander with Differential Opening (EDO) which has two screws; one anterior and one posterior. This will be done with slow expansion protocol, which is one 1/4 turn three times weekly. Petit facemask will be used to protract the retracted maxilla. The differences in measurements between before and after treatment will be assessed by cone beam computed tomography (CBCT).

Conditions

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Cleft Lip and Palate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cleft lip and palate patients

Cleft patients with transverse maxillary constriction and anteroposterior deficiency

Group Type EXPERIMENTAL

Maxillary Expander with Differential Opening (EDO)

Intervention Type DEVICE

The EDO is designed with two expansion screws positioned transversely. When more expansion is required between the canines, the anterior screw can be further activated. Both expansion screws can be activated to open in a parallel configuration. Pivoting corner screws allow for different amounts of expansion without significant risk of binding during activation.

Petit face mask

Intervention Type DEVICE

The face mask is anatomical, multi-adjustable, lightweight and an ideal therapeutic alternative for the correction of Class III malocclusion. It consists of forehead cap, chin cap, and cross bar.

Interventions

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Maxillary Expander with Differential Opening (EDO)

The EDO is designed with two expansion screws positioned transversely. When more expansion is required between the canines, the anterior screw can be further activated. Both expansion screws can be activated to open in a parallel configuration. Pivoting corner screws allow for different amounts of expansion without significant risk of binding during activation.

Intervention Type DEVICE

Petit face mask

The face mask is anatomical, multi-adjustable, lightweight and an ideal therapeutic alternative for the correction of Class III malocclusion. It consists of forehead cap, chin cap, and cross bar.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patient age ranges from 8 to 12 years.
* Patients of both sexes.
* Cleft lip and palate patients.
* All the cases showed maxillary arch constriction and deficiency.
* All patients had maxillary permanent first molars.
* Primary lip adhesion and palatal closure.

Exclusion Criteria

* Patients had received any surgical assisted rapid maxillary expansion or maxillary protraction of fixed orthodontics before.
* Maxillary dentition unsuitable to bond the expander (less than two dental units beside permanent first molar).
* Absent maxillary permanent first molars.
* Uncooperative patients/parents.

Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes