Evaluation Of Anchorage Control During Canine Retraction Using Arch Wire Stopper Versus Mini-Screws

Evaluation Of Anchorage Control During Canine Retraction Using Arch Wire Stopper in Comparison to Mini-Screws in Post-Pubertal Patients: A Randomized Clinical Trial

The study aims to compare the anchorage control during canine retraction using arch wire stopper versus mini-screws in post-pubertal patients with maxillary dentoalveolar protrusion

Study Overview

• Status: Recruiting
• Conditions: Orthodontic Appliance Complication
• Intervention / Treatment: Device: archwire stopper mesial to the maxillary first molar group; Device: inter-radicular mini-screw

Detailed Description

The study begins with patient selection according to inclusion and exclusion criteria, followed by treatment planning, and then bonding of orthodontic brackets of the upper and lower arches, including the second maxillary molars.

After leveling and alignment for all participants, the extraction of the maxillary first premolars will be performed.

• In the "Intervention Group" Canine retraction will be performed on 0.017×0.025 ss archwire with an archwire stopper mesial to the upper first molar.
• In the "Comparator Group" Canine retraction on 0.017×0.025 ss archwire with the upper first molars indirectly anchored to inter-radicular mini screws

Lastly, the anchorage control in both groups and the secondary outcomes will be assessed using the obtained digital models and lateral cephalometric radiographs.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mennatallah Ali; Phone Number: 01018509275; Email: mennatallah.moamen@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 12613
    • Recruiting
    • Faculty of Dentistry, Cairo University
    • Contact: Mennatallah Moamen, BDS; Phone Number: +201018509275; Email: mennatallah.moamen@dentistry.cu.edu.eg
    • Principal Investigator: Mennatallah Moamen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Post-pubertal female patients.
• Cases with bimaxillary protrusion or Class II Division 1 malocclusion that require maxillary first premolars extraction.
• Full permanent dentition (not necessitating third molars).
• Good oral hygiene.

Exclusion Criteria:

• Medically compromised patients.
• Active periodontal disease or obvious bone loss in the maxillary arch.
• Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).
• Smoking or any systemic diseases.
• Chronic use of any medications including antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers. All the above factors affect the rate of tooth movement
• Previous orthodontic treatment.
• Missing teeth.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: arch wire stopper mesial to the maxillary first molar group; In postpubertal female patients with maxillary dentoalveolar protrusion, canine retraction after the extraction of the maxillary first premolars with archwire stoppers mesial to the maxillary first molars.	Device: archwire stopper mesial to the maxillary first molar group; canine retraction after the extraction of the maxillary first premolars with archwire stoppers is mesial to the maxillary first molars.
Active Comparator: maxillary first molar indirectly anchored to the inter-radicular mini-screw group; In postpubertal female patients with maxillary dentoalveolar protrusion, canine retraction after the extraction of the maxillary first premolars, with the maxillary first molars indirectly anchored to the inter-radicular mini-screw.	Device: inter-radicular mini-screw; canine retraction after the extraction of the maxillary first premolars, with the maxillary first molars indirectly anchored to the inter-radicular mini-screw.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of anchorage loss of the maxillary first molars	After full canine retraction, the amount of anchorage loss (mesial movement) of the maxillary first molars of will be assessed on the digital models	6 months from the start of the canine retraction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tipping of the maxillary first molar.	the degree of tipping of the maxillary first molars will be assessed on the lateral cephalometric radiograph	6 months from the start of the canine retraction
Maxillary incisors inclination	The change in the maxillary incisors inclination will be assessed on the lateral cephalometric radiograph	6 months from the start of the canine retraction

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mennatallah Ali, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: May 12, 2024
• First Submitted That Met QC Criteria: May 12, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ORTH3-3-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No