The Effect of a Newly Designed Presurgical Orthopedic Appliance

Study Overview
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Brief Summary
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A randomized clinical trial to compare the effectiveness of newly designed active type of presurgical orthopedic appliances on maxillary arch dimensions in infants with bilateral cleft lip and palate.

Detailed Description
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It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: a passive orthopedic appliance will be used, and group two a new designed active orthopedic appliance will be used. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment.

Official Title
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The Effect of a Newly Designed Presurgical Orthopedic Appliance on Maxillary Arch Dimensions in Infants With Bilateral Cleft Lip and Palate: Randomized Clinical Trial

Conditions
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Cleft Lip and Palate

Intervention / Treatment
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* Device: Active PSIO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Healthy new born infants with complete bilateral cleft lip, alveolus and palate. 2. Non-syndromic. 3. Non-operated cases. Exclusion Criteria: 1. Infants with systemic syndromes. 2.Facial deformities.

Ages Eligible for Study
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Minimum Age: 5 Days
Maximum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Passive PSIO will be used | |
| Experimental: Experimental<br>Active PSIO will be used | Device: Active PSIO<br>* new designed active orthopedic appliance will be used. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arch dimension (experimental group and control group) | Evaluation of the efficiency of a newly designed presurgical infant orthopedic for bilateral cleft lip and palate patients by measuring the maxillary arch dimension at the beginning and end of treatment in both experimental and control group. | T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parents Perception and experience | The perception and experience of parents of children with cleft lip and palate concerning the use presurgical infant orthopedics using a questionnaire-based cross sectional survey. The assessment of mothers' perception and experience regarding PSIO will be executed using 16 validated preformed questions. The onset of the sign of the positive correction of the cleft segments will be recorded accordingly. In addition, PSIO management, including the removable appliance's hygiene maintenance, was also assessed. | T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months) | 
| Linear measurement (experimental group and control group) | The linear measurements of arch dimensions in millimeter before and after treatment with the new presurgical infant orthopedic within the cleft patients in both experimental and control group. Linear measurements for maxillary arch assessments in millimeters: Antero-posterior arch length (I-RTLT) Posterior arch width (RT-LT) Alveolar cleft widths (AP); Right: RP-RA and left: LP-LA Mid-palatal arch width (RM-LM) | T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months) | 
| Angular measurement (experimental group and control group) | The angular measurements of arch dimensions before and after treatment with the new presurgical infant orthopedic within the cleft patients in both experimental and control group. Angular measurements for maxillary arch assessments in degrees: Vertical deviation amount of premaxilla Horizontal deviation amount of premaxilla | T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months) | 
| Vertical measurement (experimental group and control group) | The vertical measurements of arch dimensions in millimeter before and after treatment with the new presurgical infant orthopedic within the cleft patients in both experimental and control group. Vertical measurements for maxillary arch assessments in millimeters: The height of alveolar bone at RM The height of alveolar bone at LM | T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cleft lip and palate, Bilateral, Presurgical orthopaedic appliance