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

Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars Using Infra Zygomatic Mini Implants: A Prospective Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Class II Malocclusion
• Intervention / Treatment: Device: Intra-Oral Distalizing Device

Detailed Description

The appliances available for distalization used to be mainly extraoral distalizing appliances which depended entirely on patient cooperation and compliance. Even after the emergence of intra-oral distalizing appliances they had adverse dentoalveolar effect such as anchorage loss and flaring of the upper anterior teeth. Thus, this study was made in order to evaluate the efficiency of our proposed appliance in the treatment of Class II patients while avoiding the adverse effects mentioned above.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • New Cairo, Cairo, Egypt, 11835
      • Future University in Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intra-oral Distalizing Appliance; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Intermolar width in mm.	Effect of the proposed appliance on the transverse Dental changes in the upper buccal segment through scanned dental cast in millimetres	Up until Class I Molar Relation (a maximum of 8 months regardless)
Changes of Molar inclination in degrees.	Effect of the proposed appliance on the angulation of the first permanent molar through scanned dental cast and cone-beam computed tomography (CBCT) in degrees.	Up until Class I Molar Relation (a maximum of 8 months regardless)

Collaborators and Investigators

• Sponsor: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: June 5, 2021
• First Submitted That Met QC Criteria: October 20, 2022
• First Posted (Actual): October 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Distalization; Intermolar Width; Molar Inclination; Intra-oral Appliance; Infrazygomatic Mini-screws
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: FUE.REC(23)/11-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected individual participant data (IPD)
• IPD Sharing Time Frame: Data will be available after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No