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

Bimaxillary Protrusion Clinical Trial

Official title:

Evaluation of the Rate of Anterior Segment Retraction Using Friction Versus Frictionless Mechanics: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04892056
• Other study ID #: FUE.REC 9/10-2018
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 15, 2020

Study information

• Verified date: May 2021
• Source: Future University in Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 15, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bimaxillary Protrusion

Intervention

Other:
• Friction Mechanics
anterior segment retraction using elastomeric power chains
• Frictionless Mechanics
anterior segment retraction using closing loops

Locations

Country	Name	City	State
Egypt	Future Univeristy in Egypt	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Anchorage Loss	Mesial movement of the first primary molar was evaluated on the digital models	The start of anterior segment retraction up to complete space closure, an average of 6 months.
Secondary	Pain experienced after each activation of the two mechanics	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.	The start of anterior segment retraction up to complete space closure, an average of 6 months.