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Completed

NCT Number: NCT06240923

"Three Dimensional Assessment of Maxillary Molars Following Distalization Using Two Different Approaches"

The goal of this controlled clinical trial is to compare the effects of two distalization methods supported by inter-radicular mini-screw for maxillary molars distalization in 20 adult patients with skeletal class I or moderate skeletal class II malocclusion, dental class II molar relationship, and full permanent dentition. The participants were randomly selected according to inclusion / exclusion criteria from the outpatient clinic of the Department of Orthodontics and Dentofacial Orthopedics, Faculty of dentistry, Ain Shams University, Cairo, Egypt. Selectees age was ranging from 18 to 25 years old.

An informed consent has been signed by each patient before his / her enrollment in this study, where the aim , methodology, and possible complications were been clearly described in details. This research has been thoroughly reviewed by the Research Ethics Committee of the Faculty of dentistry, Ain Shams University.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 11566, Egypt

About this study

This study is a two-arm, parallel group, prospective randomized clinical trial with the allocation ratio of 1:1. The Consolidated Standards of Reporting Trials (CONSORT statement) were used as a guide for this study.

After reviewing the study protocol, the ethical committee at the Faculty of Dentistry, Ain-Shams University approved the study.

Before treatment was carried out, a detailed written Arabic consent was signed by all the subjects of both groups after full explanation of the aim of the study and the procedures.

This prospective clinical study was conducted on a total of 24 maxillary first molars.

No financial competing interests: This study was part of a Masters' degree in Orthodontics, Faculty of Dentistry, Ain-Shams University.

No financial conflicts of interest were declared. The study was self- funded by the principal investigator.

A sample size of 24 distalizing sites was selected and divided into two groups twelve each:

Group 1: Single coil spring. Group 2: Double coil spring.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • All subjects are free from any dental anomalies as well as periodontal and systemic diseases that may influence orthodontic treatment.
  • Adult patients with age ranging from 18 to 25 years.
  • Full permanent dentition with exclusion of third molars.
  • Both first and second maxillary molars are in occlusion.
  • Skeletal class I, mild or moderate skeletal class II malocclusion.
  • Full cusp or end to end class II molar relationship.
  • Mild to moderate crowding in the upper dental arch and / or increased overjet.
  • Normal or horizontal growth pattern.
  • Non-extraction treatment plan.

Exclusion criteria

  • Previous orthodontic treatment.
  • Treatment planning requiring orthognathic surgery.
  • Severe molar rotation.
  • Poor oral hygiene.

Treatment and study plan

Maxillary molars distalization

Device

Maxillary molars distalization by using a nickel titanium open coil spring as an posterior displacement device.

Other names: Posterior displacement of maxillary molars

Primary outcomes

  1. The amount of maxillary molars distalization

    Time frame: 8-10 months

    Primary outcome of this study is to determine the amount of maxillary molars linear distal movement distance measured in millimeters.

  2. The type of maxillary molars distalization

    Time frame: 8-10 months

    Molar tipping measured by the degree of the angle of tipping.

Secondary outcomes

  1. Loss of anchorage

    Time frame: 8-10 months

    Anterior linear displacement of the premolars measured in millimeters.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Feb 5, 2024
Registry last updated
Feb 5, 2024

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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