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

Orthodontic Appliance Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06416904
• Other study ID #: ORTH3-3-3
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2024
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: Mennatallah Ali
• Phone: 01018509275
• Email: mennatallah.moamen[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Orthodontic Appliance Complication

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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