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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05592977
Enrollment
10
Registered
2022-10-25
Start date
2020-11-09
Completion date
2022-12-01
Last updated
2023-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class II Malocclusion

Keywords

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

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.

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.

Interventions

DEVICEIntra-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

Sponsors

Future University in Egypt
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

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

Eligibility

Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
linear distalization of maxillary 1st molar.Up until Class I Molar Relation (a maximum of 8 months regardless)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.
Rate of maxillary 1st molar Distalization in mm/ month.Up until Class I Molar Relation (a maximum of 8 months regardless)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.

Secondary

MeasureTime frameDescription
Changes in Intermolar width in mm.Up until Class I Molar Relation (a maximum of 8 months regardless)Effect of the proposed appliance on the transverse Dental changes in the upper buccal segment through scanned dental cast in millimetres
Changes of Molar inclination in degrees.Up until Class I Molar Relation (a maximum of 8 months regardless)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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026