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Completed

NCT Number: NCT06416904

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

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

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Key information

Age range

15 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, 12613, Egypt

About this study

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.

Afterwards, anterior segment retraction will be done using T-loop on 0.017x0.025 TMA archwire

  • 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 Afterwards, anterior segment retraction will be done using T-loop on 0.017x0.025 TMA archwire

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

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

archwire stopper mesial to the maxillary first molar group

Device

canine retraction after the extraction of the maxillary first premolars with archwire stoppers is mesial to the maxillary first molars.

inter-radicular mini-screw

Device

canine retraction after the extraction of the maxillary first premolars, with the maxillary first molars indirectly anchored to the inter-radicular mini-screw.

Primary outcomes

  1. Amount of anchorage loss of the maxillary first molars

    Time frame: 6 months from the start of the canine retraction and after anterior segment retraction (12 months)

    After full canine retraction, the amount of anchorage loss (mesial movement) of the maxillary first molars of will be assessed on the digital models

Secondary outcomes

  1. Tipping of the maxillary first molar.

    Time frame: 6 months from the start of the canine retraction and after anterior segment retraction (12 months)

    the degree of tipping of the maxillary first molars will be assessed on the lateral cephalometric radiograph

  2. Maxillary incisors inclination

    Time frame: 6 months from the start of the canine retraction and after anterior segment retraction (12 months)

    The change in the maxillary incisors inclination will be assessed on the lateral cephalometric radiograph

  3. Maxillary incisors anteroposterior position

    Time frame: 6 months from the start of the canine retraction and after anterior segment retraction (12 months)

    The change in the maxillary incisors anteroposterior position will be assessed on the lateral cephalometric radiograph and digital models

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Feb 11, 2026

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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