Evaluation of the Rate of Anterior Segment Retraction Using Two Types of Mechanics

NCT04892056 | Completed

• 1 other identifier: FUE.REC 9/10-2018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The rate of anterior segment retraction in bi-maxillary protrusion cases was evaluated comparing the friction and friction-less mechanics. since, there has been a lack of clear cut guidelines for clinicians for the optimum method for retraction, this randomized clinical trial was done.

Conditions

Bimaxillary Protrusion

Keywords

T loops; Friction; Frictionless; power chains; digital models; anterior segment retraction

Outcome Measures

Primary Outcomes (1)

• Rate of Anterior Segment Retraction

  The rate of anterior segment retraction per month was measured on monthly digital models.

  The start of anterior segment retraction up to complete space closure, an average of 6 months.

Secondary Outcomes (2)

• Anchorage Loss

  The start of anterior segment retraction up to complete space closure, an average of 6 months.

• Pain experienced after each activation of the two mechanics

  The start of anterior segment retraction up to complete space closure, an average of 6 months.

Study Arms (2)

Anterior Segment Retraction using Friction mechanics by elastomeric power chains

EXPERIMENTAL

Elastomeric power chains extending from 8mm crimpable hooks, distal to the lateral incisors, on 0.017"x0.025" Stainless Steel WIres, to the mini-screws. The power chains delivered 160g of force per side.

Other: Friction Mechanics

Anterior Segment Retraction using Frictionless mechanics by T-loops

EXPERIMENTAL

T shaped closing loops were fabricated on 0.017"x0.025" Titanium- Molybdenum wires (TMA) were used to deliver 160g of force per side by 4mm distal activations.

Other: Frictionless Mechanics

Interventions

Friction Mechanics OTHER

anterior segment retraction using elastomeric power chains

Also known as: sliding mechanics

Anterior Segment Retraction using Friction mechanics by elastomeric power chains

Frictionless Mechanics OTHER

anterior segment retraction using closing loops

Also known as: segmented mechanics

Anterior Segment Retraction using Frictionless mechanics by T-loops

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female Subjects.
• Age 13-25 y of age.
• Skeletal Angle Class I malocclusion with Bimaxillary dentoalveolar protrusion in need of four 1st premolar extractions with maximum anchorage.
• Fully erupted permanent dentition without crowding.
• Good oral and general health.

You may not qualify if:

• Systemic Diseases or syndromes or on anti-inflammatory medication.
• Extracted or missing permanent teeth.
• History of previous Orthodontic Treatment.
• Parafunctional Habits.
• Badly decayed teeth.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future Univeristy in Egypt

Cairo, Egypt

Location

Study Officials

• Yehia Mostafa, Chairman

  Future Univeristy in Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of the principal investigator was not possible due to the nature of the interventions. However, the outcome assessor was blinded to the interventions and all digital models were unidentified during outcome assessment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 19, 2021
• Study Start: February 1, 2019
• Primary Completion: June 10, 2020
• Study Completion: December 15, 2020
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After Publication

Locations

EG (1)