Mandibular First Molar Distalization

Class III Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04229797
• Other study ID #: MakhloufOrth
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2024
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Mohamed Kh Makhlouf
• Phone: =201001405334
• Email: mmakhlouf[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Class III Malocclusion
• Malocclusion
• Malocclusion, Angle Class III
• Prognathism

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 months