Mandibular First Molar Distalization
Primary Purpose
Class III Malocclusion
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Mandibular distalization using extra-radicular miniscrews
Sponsored by
About this trial
This is an interventional treatment trial for Class III Malocclusion focused on measuring Class III malocclusion, Mandibular buccal shelf, Mini-screws, Extra-radicular mini-screws, Distalization, Temporary Anchorage device
Eligibility Criteria
Inclusion Criteria:
- Class III dental incisal relation.
- Dental canine and molar relation not more than half unit Class III.
- Presence of unerupted mandibular third molars on both sides.
- Skeletal Class I or mild Class III.
- Full Permanent dentition.
- Medically free subjects.
Exclusion Criteria:
- Patients with systemic diseases or neuromuscular disorders.
- Retroclined lower incisors.
- Sever skeletal dysplasia.
- Patients with periodontal disease.
Sites / Locations
- Faculty of Dentistry, Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Comparator
Intervention
Arm Description
Extraction of the unerupted third molars before distalization of mandibular first molar using Mandibular buccal shelf mini-screws.
Leaving the unerupted third molars and distalizing using Mandibular buccal shelf mini-screws.
Outcomes
Primary Outcome Measures
Dental effect
Amount of first mandibular molar distalization (mm) in the two groups, A cephalometric of pre and post distalization digital cephalograms will be traced, landmarks and reference lines will be determined; skeleto-dental and soft tissue measurements will be performed using Quick-Ceph program .
Digital models of pre and post distalization will be superimposed and measured for dental changes using Anatomage program.
Secondary Outcome Measures
Skeletal and soft tissue effect
Skeletal and soft tissue changes post distalization, A cephalometric of pre and post distalization digital cephalograms will be traced, landmarks and reference lines will be determined; skeleto-dental and soft tissue measurements will be performed using Quick-Ceph program.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04229797
Brief Title
Mandibular First Molar Distalization
Official Title
The Efficacy of Mandibular First Molar Distalization Using Extra Radicular Miniscrews in Class III Patients: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
March 2024 (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
No
5. Study Description
Brief Summary
A clinical study to test the capability of the mini-screws inserted in the Mandibular buccal shelf area as an anchorage unit to distalize mandibular first molar for correction of mild to moderate Class III cases. The second aim was to detect if there is a difference in the amount of distalization in the presence of unerupted mandibular third molars, using the same technique.
Detailed Description
Class III malocclusion in adults is one of the most complex malocclusions in clinical orthodontics. For adults, the ideal treatment option for Class III malocclusion is accomplished either by camouflage treatment in mild to moderate cases or orthognathic surgery in severe cases. Camouflage treatment for Class III malocclusion comprises three main techniques; Class III elastics, mandibular first molar distalization, or extraction of mandibular first premolars. Mandibular first molar distalization via the use of skeletal anchorage has the problem of increased failure rate of the inter-radicular temporary anchorage devices (TADs). Accordingly, a randomized clinical trial using extra radicular TADs in the Mandibular buccal shelf area was designed in the current research aiming to test the efficacy of such a technique in inducing mandibular molar distalization with decreased failure rate, and whether the presence of unerupted mandibular third molars will affect the distalization movement or not.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class III Malocclusion
Keywords
Class III malocclusion, Mandibular buccal shelf, Mini-screws, Extra-radicular mini-screws, Distalization, Temporary Anchorage device
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
Extraction of the unerupted third molars before distalization of mandibular first molar using Mandibular buccal shelf mini-screws.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Leaving the unerupted third molars and distalizing using Mandibular buccal shelf mini-screws.
Intervention Type
Procedure
Intervention Name(s)
Mandibular distalization using extra-radicular miniscrews
Intervention Description
Distalization of the Mandibular first molars using mandibular buccal shelf mini-screws in the presence of unerupted third molars
Primary Outcome Measure Information:
Title
Dental effect
Description
Amount of first mandibular molar distalization (mm) in the two groups, A cephalometric of pre and post distalization digital cephalograms will be traced, landmarks and reference lines will be determined; skeleto-dental and soft tissue measurements will be performed using Quick-Ceph program .
Digital models of pre and post distalization will be superimposed and measured for dental changes using Anatomage program.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Skeletal and soft tissue effect
Description
Skeletal and soft tissue changes post distalization, A cephalometric of pre and post distalization digital cephalograms will be traced, landmarks and reference lines will be determined; skeleto-dental and soft tissue measurements will be performed using Quick-Ceph program.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Class III dental incisal relation.
Dental canine and molar relation not more than half unit Class III.
Presence of unerupted mandibular third molars on both sides.
Skeletal Class I or mild Class III.
Full Permanent dentition.
Medically free subjects.
Exclusion Criteria:
Patients with systemic diseases or neuromuscular disorders.
Retroclined lower incisors.
Sever skeletal dysplasia.
Patients with periodontal disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Kh Makhlouf
Phone
=201001405334
Email
mmakhlouf@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Mo Eldawlatly, Lecturer
Phone
+201006619898
Email
mostafaeldawlatly@gmail.com
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
State/Province
Giza
ZIP/Postal Code
12411
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Kh Makhlouf
Phone
+201001405334
Email
mmakhlouf@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Mandibular First Molar Distalization
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