Class II Malocclusion Correction Using the Mini-screw Supported Advanced Molar Distalization Appliance

NCT06726694 | Completed DMC

• 1 other identifier: Distalization
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

the primary aim for this clinical trial was to assess the amount of molar distalization The subjects with the following inclusion criteria:

1. 1.Early permanent dention.
2. 2.Class II division 1 or class II division 2 dental occlusion.
3. 3.Good oral hygiene.
4. 4.No previous orthodontic treatment.
5. 5.No history of serious medical problems such as diabetes or autoimmune disease, allergies or bone disease.
6. 6.Good periodontal support of the upper molar.

Conditions

Class II Malocclusion

Keywords

Disatlization; class II; growing patient; molar tipping

Outcome Measures

Primary Outcomes (1)

• amount of molar distalization

  measuring the amount of molar distalization in millimeter by cephalometric analysis

  8 months

Study Arms (1)

class II malocclusion patients

ACTIVE COMPARATOR

class II molar relation correction by advanced maxillary molar distalization appliance

Device: class II molar relation correction by advanced molar distalization appliance

Interventions

class II molar relation correction by advanced molar distalization appliance DEVICE

correction of class II molar relation by a novel miniscrews distalizer

Also known as: AMDA, miniscrews supported distalizer

class II malocclusion patients

Eligibility Criteria

• Age: 11 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Early permanent dention.
• Class II division 1 or class II division 2 dental occlusion.
• Good oral hygiene.
• No previous orthodontic treatment.
• No history of serious medical problems such as diabetes or autoimmune disease, allergies or bone disease.
• Good periodontal support of the upper molar.

You may not qualify if:

• Patients with severe crowding requiring extraction.
• Vertical growth patterns.
• Syndromic patients.
• Vulnerable groups.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbasia, 3753450, Egypt

Location

Related Publications (1)

• Papadopoulos MA. Efficient Distalization of Maxillary Molars with Temporary Anchorage Devices for the Treatment of Class II Malocclusion. Turk J Orthod. 2020 Aug 20;33(3):197-201. doi: 10.5152/TurkJOrthod.2020.20064. eCollection 2020 Sep.

  PMID: 32974067 BACKGROUND

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class II; Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 10, 2024
• Study Start: May 20, 2020
• Primary Completion: May 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 10, 2024

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 1\| 2\| 2025 1\| 5 \| 2025
• Access Criteria: Noha Ibrahim google drive 5 \| 2025

Locations

EG (1)