Back to resultsTransverse Dento-skeletal Effects of Two Rapid Palatal Expansion Appliances in Cleft Lip and Palate Patients
Primary Purpose
Cleft Lip and Palate
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hyrax appliance
haas appliance
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Lip and Palate focused on measuring maxillary expansion
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
hyrax group
haas group
Arm Description
cleft lip and palate patients with hyrax appliance
cleft lip and palate patients with haas appliance
Outcomes
Primary Outcome Measures
Tranverse dental changes
assessed on digital models by linear measurements (mm)
Tranverse dental changes
assessed on digital models by linear measurements(mm)
Tranverse skeletal changes
assessed on CBCT by linear and angular measurements(mm and angles)
Secondary Outcome Measures
Maxillary and mandibular anteroposterior measurements
They will be measured on digital casts by linear measurements(mm)
Maxillary and mandibular anteroposterior measurements
They will be measured on digital casts by linear measurements(mm)
Maxillary and mandibular anteroposterior measurements
They will be measured on CBCT by linear and angular measurements(mm and angles)
Vertical skeletal measurents
They will be measured on CBCT by linear and angular measurements(mm and angles)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04236466
Brief Title
Transverse Dento-skeletal Effects of Two Rapid Palatal Expansion Appliances in Cleft Lip and Palate Patients
Official Title
Transverse Dento-skeletal Effects of Two Rapid Palatal Expansion Appliances in Cleft Lip and Palate Patients : A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2020 (Anticipated)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
•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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip and Palate
Keywords
maxillary expansion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hyrax group
Arm Type
Experimental
Arm Description
cleft lip and palate patients with hyrax appliance
Arm Title
haas group
Arm Type
Experimental
Arm Description
cleft lip and palate patients with haas appliance
Intervention Type
Device
Intervention Name(s)
hyrax appliance
Intervention Description
Hyrax will be constructed with bands on maxillary first molars and wire extending on palatal surfaces of teeth till the upper canines.
Intervention Type
Device
Intervention Name(s)
haas appliance
Intervention Description
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
Primary Outcome Measure Information:
Title
Tranverse dental changes
Description
assessed on digital models by linear measurements (mm)
Time Frame
3 months
Title
Tranverse dental changes
Description
assessed on digital models by linear measurements(mm)
Time Frame
6 months
Title
Tranverse skeletal changes
Description
assessed on CBCT by linear and angular measurements(mm and angles)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Maxillary and mandibular anteroposterior measurements
Description
They will be measured on digital casts by linear measurements(mm)
Time Frame
3 months
Title
Maxillary and mandibular anteroposterior measurements
Description
They will be measured on digital casts by linear measurements(mm)
Time Frame
6 months
Title
Maxillary and mandibular anteroposterior measurements
Description
They will be measured on CBCT by linear and angular measurements(mm and angles)
Time Frame
6 months
Title
Vertical skeletal measurents
Description
They will be measured on CBCT by linear and angular measurements(mm and angles)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yomna ElFiky
Phone
01001987078
Ext
01001987078
Email
princessyomna7@outlook.com
12. IPD Sharing Statement
Learn more about this trial
Transverse Dento-skeletal Effects of Two Rapid Palatal Expansion Appliances in Cleft Lip and Palate Patients
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