An interventional study of Mandibular distalization using extra-radicular miniscrews in Class III Malocclusion, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 16 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.
This study's planned enrollment of 20 is below the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.
Browse Malocclusion, Angle Class III studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Extraction of the unerupted third molars before distalization of mandibular first molar using Mandibular buccal shelf mini-screws.
Procedure: Mandibular distalization using extra-radicular miniscrews
Leaving the unerupted third molars and distalizing using Mandibular buccal shelf mini-screws.
Procedure: Mandibular distalization using extra-radicular miniscrews
Distalization of the Mandibular first molars using mandibular buccal shelf mini-screws in the presence of unerupted third molars
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.
Time frame: 6 months
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.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2024; primary completion for Feb 2025, 2 months later.
Of 37 non-industry interventional studies with no phase under Malocclusion, Angle Class III, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's planned 2 months is below that.
Counting every sponsor, half of 38 studies reached it within 13 months; a quarter within 10 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Malocclusion, Angle Class III →