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Completed

NCT Number: NCT04892056

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

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.

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Key information

Conditions

Bimaxillary Protrusion

Age range

13 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Future Univeristy in Egypt

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Friction Mechanics

Other

anterior segment retraction using elastomeric power chains

Other names: sliding mechanics

Frictionless Mechanics

Other

anterior segment retraction using closing loops

Other names: segmented mechanics

Primary outcomes

  1. Rate of Anterior Segment Retraction

    Time frame: 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 outcomes

  1. Anchorage Loss

    Time frame: 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

  2. Pain experienced after each activation of the two mechanics

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 19, 2021
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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