"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.

Study Overview

• Status: Completed
• Conditions: Malocclusion, Angle Class II
• Intervention / Treatment: Device: Maxillary molars distalization

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11566
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Single coil spring; A single open coil spring was inserted between the maxillary second premolar and the maxillary first molar with a distalizing force 300 gm.	Device: Maxillary molars distalization; Maxillary molars distalization by using a nickel titanium open coil spring as an posterior displacement device.; Other Names: Posterior displacement of maxillary molars
Experimental: Group 2: Double coil spring; 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.	Device: Maxillary molars distalization; Maxillary molars distalization by using a nickel titanium open coil spring as an posterior displacement device.; Other Names: Posterior displacement of maxillary molars

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loss of anchorage	Anterior linear displacement of the premolars measured in millimeters.	8-10 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Noha I Abdelrahman, Assoc. Prof., Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2017
• Primary Completion (Actual): March 16, 2022
• Study Completion (Actual): June 23, 2022

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Estimated): February 5, 2024

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Dental malocclusion
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: ORD 16-6M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No