Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars

NCT05592977 | Completed

• 1 other identifier: FUE.REC(23)/11-2020
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

There is a scarcity in the current literature regarding such appliance and its effect on distalizing the first maxillary molar in absence of the second molar. Therefore, this study was made to evaluate the effect of bilateral distalization of upper first molars in a group of patients after extraction of maxillary second Molars using infra zygomatic mini implants.

Conditions

Class II Malocclusion

Keywords

Intermolar Width; Molar Inclination; Intra-oral Appliance; Infrazygomatic Mini-screws; Distalization

Outcome Measures

Primary Outcomes (2)

• linear distalization of maxillary 1st molar.

  Efficiency of the proposed appliance to induce distalization of the upper 1st molar measured on Scanned dental casts as well as cone-beam computed tomography (CBCT) in millimetres.

  Up until Class I Molar Relation (a maximum of 8 months regardless)

• Rate of maxillary 1st molar Distalization in mm/ month.

  Efficiency of the proposed appliance to induce distalization of the upper 1st molar measured on Scanned dental casts with a monthly follow up in millimetres.

  Up until Class I Molar Relation (a maximum of 8 months regardless)

Secondary Outcomes (2)

• Changes in Intermolar width in mm.

  Up until Class I Molar Relation (a maximum of 8 months regardless)

• Changes of Molar inclination in degrees.

  Up until Class I Molar Relation (a maximum of 8 months regardless)

Study Arms (1)

Intra-oral Distalizing Appliance

EXPERIMENTAL

Two infra zygomatic mini-implants will be placed Bands will be cemented to upper first molars. The inner bow (1.2mm) is a modified version of the inner part of a conventional face bow. Two hooks were soldered onto the inner bow distal to the lateral incisor teeth regions, and U loop at 1st premolar region, and bends acting as mesial stop will be bent in front of the maxillary first molars. Orthodontic force 300 mg per side Will be delivered by Niti closed coil spring which is attached from infra zygomatic mini screw to the hook soldered to the wire framework.

Device: Intra-Oral Distalizing Device

Interventions

Intra-Oral Distalizing Device DEVICE

The inner bow (1.2mm) is a modified version of the inner part of a conventional face bow. Two hooks were soldered onto the inner bow distal to the lateral incisor teeth regions, and U loop at 1st premolar region, and bends acting as mesial stop will be bent in front of the maxillary first molars. The anterior component of the inner bow is 3 mm free from the labial surface of anterior teeth

Intra-oral Distalizing Appliance

Eligibility Criteria

• Age: 16 Years+
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female Patients with cervical vertebra maturation index (CVMI) 5 \& 6.
• From quarter unit to 3\\4-unit class II molar relationship.
• An overjet of an average 6mm.
• Full Set of permanent dentition except for the maxillary second molar.
• Favorable path of eruption for the maxillary third molar.

You may not qualify if:

• Medically compromised Patients.
• Patients under long term medications.
• Patients having sever periodontal disease.
• CVMI 3 or less
• Full unit class II cases

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future University In Egypt

New Cairo, Cairo Governorate, 11835, Egypt

Location

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

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

Study Officials

• Yehia Mostafa, Professr and Chairman

  Future University in Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Due to the nature of the study, the operator and patients can't be blinded. Blinding of the outcome assessors can be done by sealing the name of the patient in the pre and post treatment radiographs used for analysis
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: June 5, 2021
• First Posted: October 25, 2022
• Study Start: November 9, 2020
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available after publication

Locations

EG (1)