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

NCT06240923 | Completed DMC

• 1 other identifier: ORD 16-6M
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion, Angle Class II

Keywords

Dental malocclusion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Loss of anchorage

  8-10 months

Study Arms (2)

Group 1: Single coil spring

EXPERIMENTAL

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

Group 2: Double coil spring

EXPERIMENTAL

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

Interventions

Maxillary molars distalization DEVICE

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

Also known as: Posterior displacement of maxillary molars

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

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II; Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Noha I Abdelrahman, Assoc. Prof.

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: A sample size of 24 maxillary dental distalizing sites were selected and divided into two groups twelve in each: Group 1: Single coil spring. Group 2: Double coil spring.

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: February 5, 2024
• Study Start: January 2, 2017
• Primary Completion: March 16, 2022
• Study Completion: June 23, 2022
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)