Back to resultsEn Masse Distaliaztion Via Skeletal Anchorage
Primary Purpose
Orthodontic Appliance Complication, Angle Class II Patients, Distalization
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Distalization
Sponsored by
About this trial
This is an interventional treatment trial for Orthodontic Appliance Complication, Angle Class II Patients, Distalization
Eligibility Criteria
Inclusion Criteria:
- Full set of permanent teeth present, except for third molar
- Bilateral Class II malocclusion with a mesial migration of maxillary posterior teeth
- No systemic conditions interfering with treatment, as reported by patient
- No previous Orthodontic treatment
- Good Oral Hygiene
- No use of any for of anti-inflammatory drugs
Exclusion Criteria:
- Patient who required surgery to correct skeletal discrepancies
- Patient with congenital dentoskeletal disorders
- Missed or Mutilated teeth in Maxillary arch
- Patients with poor oral hygiene
Sites / Locations
- Al-Azhar University, faculty of dental medicine orthodontic clinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Skeletally anchored Distal Jet appliance
Skeletally anchored Hyrax screw distalizer
Arm Description
Outcomes
Primary Outcome Measures
Amount of distalization
difference in initial and final position of maxillary posterior segment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05245929
Brief Title
En Masse Distaliaztion Via Skeletal Anchorage
Official Title
Evaluation of Two Bone Anchored Appliances for en Masse Distalization of Maxillary Buccal Segment in Class II Patients: A Comparative Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
Comparing the efficacy and performance of two conventionally anchored distalizers after modifying them to be skeletally anchored. En masse distalization is attempted by consolidating the posterior maxillary segment "first premolar to second molar" as one unit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthodontic Appliance Complication, Angle Class II Patients, Distalization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Skeletally anchored Distal Jet appliance
Arm Type
Active Comparator
Arm Title
Skeletally anchored Hyrax screw distalizer
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Distalization
Intervention Description
Distalizing the posterior maxillary segment
Primary Outcome Measure Information:
Title
Amount of distalization
Description
difference in initial and final position of maxillary posterior segment
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Full set of permanent teeth present, except for third molar
Bilateral Class II malocclusion with a mesial migration of maxillary posterior teeth
No systemic conditions interfering with treatment, as reported by patient
No previous Orthodontic treatment
Good Oral Hygiene
No use of any for of anti-inflammatory drugs
Exclusion Criteria:
Patient who required surgery to correct skeletal discrepancies
Patient with congenital dentoskeletal disorders
Missed or Mutilated teeth in Maxillary arch
Patients with poor oral hygiene
Facility Information:
Facility Name
Al-Azhar University, faculty of dental medicine orthodontic clinic
City
Cairo
State/Province
Nasr City
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramadan Abu Shahba, Professor
Phone
01012624339
Email
ramadan.abushahba@su.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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En Masse Distaliaztion Via Skeletal Anchorage
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