An interventional study of Maxillary molars distalization in Malocclusion, Angle Class II, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-05.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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.
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.
124 studies on the registry are indexed under Malocclusion, Angle Class II; 19 are open to participants now.
This study's enrollment of 24 is below the median of 34 across 115 interventional studies indexed under Malocclusion, Angle Class II.
Browse Malocclusion, Angle Class II studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
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.
Also known as: Posterior displacement of maxillary molars
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.
Time frame: 8-10 months
The type of maxillary molars distalization
Molar tipping measured by the degree of the angle of tipping.
Time frame: 8-10 months
Loss of anchorage
Anterior linear displacement of the premolars measured in millimeters.
Time frame: 8-10 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
Ran from Jan 2017 to primary completion in Mar 2022, 62 months.
Of 86 non-industry interventional studies with no phase under Malocclusion, Angle Class II, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 22. This study's 62 months is above that.
Counting every sponsor, half of 86 studies reached it within 15 months; a quarter within 11 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Malocclusion, Angle Class II →