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

NCT ID: NCT06240923

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-02
• Study Completion Date: 2022-06-23

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.

Conditions

Malocclusion, Angle Class II

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Maxillary molars distalization

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Maxillary molars distalization

Intervention Type: DEVICE

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

Interventions

Maxillary molars distalization

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

Intervention Type: DEVICE

Other Intervention Names

Posterior displacement of maxillary molars

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Gihan Mohamed Anwar Mohamed Khattab

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noha I Abdelrahman, Assoc. Prof.

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Ain Shams University

Cairo, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

ORD 16-6M

Identifier Type: -

Identifier Source: org_study_id