Mandibular First Molar Distalization
The Efficacy of Mandibular First Molar Distalization Using Extra Radicular Miniscrews in Class III Patients: A Randomized Clinical Trial
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
December 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedFebruary 7, 2024
February 1, 2024
2 months
January 10, 2020
February 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months
Secondary Outcomes (1)
Skeletal and soft tissue effect
6 months
Study Arms (2)
Comparator
ACTIVE COMPARATORExtraction of the unerupted third molars before distalization of mandibular first molar using Mandibular buccal shelf mini-screws.
Intervention
EXPERIMENTALLeaving the unerupted third molars and distalizing using Mandibular buccal shelf mini-screws.
Interventions
Distalization of the Mandibular first molars using mandibular buccal shelf mini-screws in the presence of unerupted third molars
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with systemic diseases or neuromuscular disorders.
- Retroclined lower incisors.
- Sever skeletal dysplasia.
- Patients with periodontal disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry, Cairo University
Cairo, Giza Governorate, 12411, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate researcher NRC
Study Record Dates
First Submitted
January 10, 2020
First Posted
January 18, 2020
Study Start
December 1, 2024
Primary Completion
February 1, 2025
Study Completion
March 1, 2025
Last Updated
February 7, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share