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Mandibular First Molar Distalization

The Efficacy of Mandibular First Molar Distalization Using Extra Radicular Miniscrews in Class III Patients: A Randomized Clinical Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04229797
Enrollment
20
Registered
2020-01-18
Start date
2024-12-31
Completion date
2025-03-31
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class III Malocclusion

Keywords

Class III malocclusion, Mandibular buccal shelf, Mini-screws, Extra-radicular mini-screws, Distalization, Temporary Anchorage device

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.

Interventions

PROCEDUREMandibular distalization using extra-radicular miniscrews

Distalization of the Mandibular first molars using mandibular buccal shelf mini-screws in the presence of unerupted third molars

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 24 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Dental effect6 monthsAmount 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

MeasureTime frameDescription
Skeletal and soft tissue effect6 monthsSkeletal 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.

Countries

Egypt

Contacts

Primary ContactMohamed Kh Makhlouf
mmakhlouf@gmail.com=201001405334
Backup ContactMostafa Mo Eldawlatly, Lecturer
mostafaeldawlatly@gmail.com+201006619898

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026