Transverse Dento-skeletal Effects of Two Rapid Palatal Expansion Appliances in Cleft Lip and Palate Patients

Study Overview
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Brief Summary
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Aim of the study: to compare the effect of Hyrax appliance and the Haas appliance improving the transverse skeletal and dental dimensions in cleft lip and palate patients during mixed dentition.

Detailed Description
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•Steps in short Full records pre-treatment. Bands selection for upper first molars then construction of expansion appliances(Haas or Hyrax) . Delivery of appliances and instructions to the patients and their parents about their activation regimen 2 quarter turns in the morning and 2 in the evening.The posterior crossbite will be measured as the distance from the palatal cusp tips of upper first molars to central fossae of lower first molars then the needed time for expansion will be calculated .When the time calculated for correction ends, we will stop activation, we will take impressions for digital models to see if real expansion occurred or not and so testing the efficiency of the two appliances. Afterthat, if correction was not yet achieved, activation of the appliances will continue till overcorrection at the molar region with the palatal cusp tip of the maxillary posterior teeth contacting the buccal cusp tip of the mandibular posterior teeth. We will then leave the appliance insitu for retention. After 6 months from the first CBCT we will take a second CBCT to see any bony changes .

Official Title
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Transverse Dento-skeletal Effects of Two Rapid Palatal Expansion Appliances in Cleft Lip and Palate Patients : A Randomized Clinical Trial

Conditions
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Cleft Lip and Palate

Intervention / Treatment
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* Device: hyrax appliance
* Device: haas appliance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) Mixed dentition; (2) Both males and females; (3) Lip repair performed between 3 and 6 months of age and palate repair performed between 12 and 24 months of age; (4) Presence of maxillary constriction and posterior crossbite and need for maxillary expansion previous to the secondary bone graft; (5) Permanent first maxillary molars present; (6) Good periodontal health; (7) No previous orthodontic treatment; Exclusion Criteria: (1) Presence of a syndrome in companion with the present cleft defect (2) Previous secondary alveolar bone grafting (3)Taking medications affecting growth

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

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 |
| --- | --- |
| Experimental: hyrax group<br>cleft lip and palate patients with hyrax appliance | Device: hyrax appliance<br>* Hyrax will be constructed with bands on maxillary first molars and wire extending on palatal surfaces of teeth till the upper canines.<br>|
| Experimental: haas group<br>cleft lip and palate patients with haas appliance | Device: haas appliance<br>* Haas will be constructed with bands on maxillary first molars and wire extending on palatal surfaces of teeth till the upper canines. Acrylic part will be added on palate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tranverse dental changes | assessed on digital models by linear measurements (mm) | 3 months | 
| Tranverse dental changes | assessed on digital models by linear measurements(mm) | 6 months | 
| Tranverse skeletal changes | assessed on CBCT by linear and angular measurements(mm and angles) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maxillary and mandibular anteroposterior measurements | They will be measured on digital casts by linear measurements(mm) | 3 months | 
| Maxillary and mandibular anteroposterior measurements | They will be measured on digital casts by linear measurements(mm) | 6 months | 
| Maxillary and mandibular anteroposterior measurements | They will be measured on CBCT by linear and angular measurements(mm and angles) | 6 months | 
| Vertical skeletal measurents | They will be measured on CBCT by linear and angular measurements(mm and angles) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maxillary expansion