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

Class II Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05592977
• Other study ID #: FUE.REC(23)/11-2020
• Status: Completed
• Phase: N/A
• Start date: November 9, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2023
• Source: Future University in Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Class II Malocclusion
• Malocclusion
• Malocclusion, Angle Class II

Intervention

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

Locations

Country	Name	City	State
Egypt	Future University In Egypt	New Cairo	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)