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

Not Applicable

Completed

• Conditions: Bimaxillary Protrusion
• Interventions: Other: Friction Mechanics; Other: Frictionless Mechanics

• Registration Number: NCT04892056
• Lead Sponsor: Future University in Egypt

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.

Detailed Description

Thirty bi-maxillary protrusion female patients were randomly allocated into either intervention groups. In the Friction group, retraction was accomplished using elastomeric power chains extending from crimpable hooks distal to the lateral incisors, on 0.017x0.025-inch Stainless Steel wires, to the mini-screws . While in the friction-less group with retraction done using T- loop springs made of 0.017x0.025-inch titanium molybdenum wires. Retraction force was set to 160g per side in both intervention groups. Activation was done every four weeks. Rate of anterior segment retraction was evaluated via digital models.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2020-06-10
• Study Completion: 2020-12-15
• Study First Submitted: 2021-04-27
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-13
• Last Update Submitted: 2021-05-13
• Study First Posted: 2021-05-19
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anterior Segment Retraction using Friction mechanics by elastomeric power chains	Friction Mechanics	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.
Anterior Segment Retraction using Frictionless mechanics by T-loops	Frictionless Mechanics	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.

Primary Outcome Measures

Name	Time	Method
Rate of Anterior Segment Retraction	The start of anterior segment retraction up to complete space closure, an average of 6 months.	The rate of anterior segment retraction per month was measured on monthly digital models.

Secondary Outcome Measures

Name	Time	Method
Anchorage Loss	The start of anterior segment retraction up to complete space closure, an average of 6 months.	Mesial movement of the first primary molar was evaluated on the digital models
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.	Patients were asked to complete Visual Analogue Scales of the degree of pain after every intervention. The scale values between 0 to 10, with 0 being no pain experienced by the patient and 10 being the highest level of pain experienced.

Trial Locations

Locations (1)

Future Univeristy in Egypt; 🇪🇬 Cairo, Egypt