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

Not Applicable

Completed

• Conditions: Malocclusion, Angle Class II
• Interventions: Device: Maxillary molars distalization

• Registration Number: NCT06240923
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-01-02
• Primary Completion: 2022-03-16
• Study Completion: 2022-06-23
• Study First Submitted: 2023-12-12
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-01
• Last Update Submitted: 2024-02-01
• Study First Posted: 2024-02-05
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

1. Previous orthodontic treatment.
2. Treatment planning requiring orthognathic surgery.
3. Severe molar rotation.
4. Poor oral hygiene.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Single coil spring	Maxillary molars distalization	A single open coil spring was inserted between the maxillary second premolar and the maxillary first molar with a distalizing force 300 gm.
Group 2: Double coil spring	Maxillary molars distalization	Two open coil springs were inserted. The first coil spring was inserted between the maxillary second premolar and the maxillary first molar with a distalization force 300gm, and the second coil spring was inserted between the maxillary first and maxillary second molar with a distalization force 200 gm.

Primary Outcome Measures

Name	Time	Method
The type of maxillary molars distalization	8-10 months	Molar tipping measured by the degree of the angle of tipping.
The amount of maxillary molars distalization	8-10 months	Primary outcome of this study is to determine the amount of maxillary molars linear distal movement distance measured in millimeters.

Secondary Outcome Measures

Name	Time	Method
Loss of anchorage	8-10 months	Anterior linear displacement of the premolars measured in millimeters.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt