Back to resultsClear Aligner Versus Removable Inclined Plane in Treatment of Anterior Crossbite
Primary Purpose
Anterior Crossbite
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
inclined plane
clear aligner
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Crossbite focused on measuring clear aligner , anterior crossbite , inclined plane
Eligibility Criteria
Inclusion Criteria:1. Patients age (7-12) years. 2. anterior crossbite 3. More than one tooth in a crossbite. 4. Favorable oral hygiene 5. No oral habits 6. ANB within the normal range i.e. (The crossbite will be diagnosed as functional or dental) - Exclusion Criteria: Systemic conditions that may interfere with the treatment. Bad habits that might jeopardize the appliance. Transverse discrepancy. Previous orthodontic treatment
Sites / Locations
- Faculty of DentistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
inclined plane
clear aligner
Arm Description
group treated with inclined plane
group treated with clear aligner
Outcomes
Primary Outcome Measures
(OHRQoL (Oral Health-related Quality of Life)
CPQ8-10 scores at two different points in time.
Secondary Outcome Measures
cephalometric analysis of data
compare cephalometric variables between two groups
3D model measurements
compare 3D model measurements variable between 2 group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06015386
Brief Title
Clear Aligner Versus Removable Inclined Plane in Treatment of Anterior Crossbite
Official Title
Clear Aligner Versus Removable Inclined Plane in Treatment of Anterior Crossbite
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2023 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura 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
the study is carried in faculty of dentistry Mansoura university to compare the efficiency and health quality life improvement between clear aligner and inclined plane in treatment of anterior crossbite
Detailed Description
the study *include 24 patient each group include 12 patient where randomly allocated and intra-oral scanning is done for them followed by software designing ,printing using PETG sheets of 0.75 in aligner group while in inclined plane the appliance is formed in conventional way.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Crossbite
Keywords
clear aligner , anterior crossbite , inclined plane
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
inclined plane
Arm Type
Experimental
Arm Description
group treated with inclined plane
Arm Title
clear aligner
Arm Type
Experimental
Arm Description
group treated with clear aligner
Intervention Type
Other
Intervention Name(s)
inclined plane
Intervention Description
2 parallel groups one treated with clear aligner and other treated using inclined plane
Intervention Type
Other
Intervention Name(s)
clear aligner
Intervention Description
2 parallel groups one treated with clear aligner and other treated using inclined plane
Primary Outcome Measure Information:
Title
(OHRQoL (Oral Health-related Quality of Life)
Description
CPQ8-10 scores at two different points in time.
Time Frame
4 month
Secondary Outcome Measure Information:
Title
cephalometric analysis of data
Description
compare cephalometric variables between two groups
Time Frame
4 month
Title
3D model measurements
Description
compare 3D model measurements variable between 2 group
Time Frame
4 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:1. Patients age (7-12) years. 2. anterior crossbite 3. More than one tooth in a crossbite. 4. Favorable oral hygiene 5. No oral habits 6. ANB within the normal range i.e. (The crossbite will be diagnosed as functional or dental)
-
Exclusion Criteria:
Systemic conditions that may interfere with the treatment.
Bad habits that might jeopardize the appliance.
Transverse discrepancy.
Previous orthodontic treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
asmaa Mohammed, BDS
Phone
1142820091
Ext
002
Email
asmaasalah@mans.edu.eg
Facility Information:
Facility Name
Faculty of Dentistry
City
El Mansura
ZIP/Postal Code
35511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asmaa Mohammed, BDS
Phone
1142820091
Ext
002
Email
asmaasalah@mans.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clear Aligner Versus Removable Inclined Plane in Treatment of Anterior Crossbite
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