Efficiency of Rigid Versus Non-rigid Indirect Anchorage During Canine Retraction: A Split Mouth Randomized Study

August 14, 2024 updated by: Ahmed El-Timamy, Cairo University
Indirect anchorage (In-A) has been broadly used for anchorage reinforcement during anterior segment retraction. The study compared between the efficacy of rigid vs non-rigid connections of In-A i during upper canine retraction in dentoalveolar protrusion cases

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fifteen female patients with dentoalveolar protrusion were included in this study. A miniscrew was inserted following levelling and alignment between the upper first molar and second premolar of both sides. Randomization was applied before first premolar extraction where one side of the arch received a rigid indirect anchorage connection (Group I) of 0.019 x 0.025-inch stainless steel (St.St) archwire from the miniscrew to the auxiliary tube of the upper first molar band, and the other side received a non-rigid indirect anchorage connection (Group II) of 0.014-inch St.St ligature ligating the upper second premolar to the miniscrew. Canine retraction was performed on 0.017 x 0.025-inch St.St archwire applying 1.5 N retraction force. The duration of the study was 7 months. Data was collected from digitized models where anchorage loss of the upper first molar relative to the frontal plane and the vertical position of the upper second premolar were measured

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Adult females Bimaxillary protrusion requiring first premolars extractions Full permanent dentition Good oral hygiene

Exclusion Criteria:

History of previous orthodontic treatment Abnormalities in teeth size and/or shape Vertical, transverse, or anteroposterior skeletal discrepancies Anti-inflammatory medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-Rigid connection
side received a non-rigid 0.014-inch St.St ligature ligating the upper second premolar to the miniscrew.
Procedure: non rigid indirect anchorage connection
a nonrigid connection is placed between the miniscrews and the second premolar to prevent mesial tooth movement.
Active Comparator: Rigid Connection
rigid wire 19 x 25 inch stst wire was place between upper first molar and the miniscrew placed between the first molar and second premolar
Procedure: rigid indirect anchorage connection
a rigid connection is placed between the miniscrews and the first molar to prevent mesial tooth movement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anchorage loss
Time Frame: 4 month
amount of anchorage loss of the upper first molar during canine retraction using digital model in mm.
4 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vertical position of the upper second premolar
Time Frame: 4 month
The secondary outcome was to assess the change in the vertical position of the upper second premolar following canine retraction using indirect anchorage using digital models in mm.
4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2023

Primary Completion (Actual)

February 1, 2024

Study Completion (Actual)

June 2, 2024

Study Registration Dates

First Submitted

February 7, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Cairo University (CairoU)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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