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Completed

NCT Number: NCT05592977

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

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.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Future University In Egypt

New Cairo, Cairo Governorate, 11835, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. linear distalization of maxillary 1st molar.

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Changes in Intermolar width in mm.

    Time frame: 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

  2. Changes of Molar inclination in degrees.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 25, 2022
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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