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Completed

NCT Number: NCT05631353

TADs Anchored vs Conventional Anchored Carriere Motion Appliance

Carriere Motion appliance (CMA) was designed to correct a Class II molar relationship into a Class I relationship by distalizing the whole posterior maxillary segment by means of class II elastics and mandibular anchorage. To revoke the adverse effects of CMA with class II elastics, we can use the CMA to distalize the maxillary posterior segment with TADs anchorage using miniscrews. The aim of this study is to evaluate TADs anchored CMA vs. conventionally anchored CMA for distalization of the maxillary buccal segment.

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Key information

Conditions

Class II Malocclusion Malocclusion Malocclusion, Angle Class II Overbite Stomatognathic Diseases Tooth Diseases

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alazhar university

Asyut, Egypt

About this study

Twenty class II malocclusion patients with age (11-16) years will be randomly allocated in the two groups:

Group I: Patients will be treated by Carriere Motion Appliance using passive lingual arch.

Group II: Patients will be treated by Carriere Motion Appliance using direct mini-screw.

For each patient, two CBCT will be obtained: one preoperatively and another after completion of distalization.

Comparing skeletal and dental measurements obtained from CBCT radiographs obtained prior to treatment (T0) and immediately after correction of class II and remval of the appliance (T1).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adolescent patients aged 11-17 years.
  • Unilateral or bilateral Class II molar relationship.
  • Bilateral Class II canine relationship.
  • No history of previous orthodontic treatment.
  • No malformed teeth, impacted teeth and unerupted teeth.
  • No systemic disease.
  • Good oral hygiene.
  • No abnormal pressure habit.
  • No periodontal diseases.
  • No missing teeth in maxillary arch.

Exclusion criteria

  • The need for extraction in the lower arch.
  • Posterior crossbite.
  • Presence of any craniofacial anomalies.
  • Patients with syndromes.

Treatment and study plan

Carriere motion appliance

Device

Patient will be randomly allocated into two groups:

Group I: conventional mandibular anchorage using passive lingual arch. Group II: anchorage by direct mini-screws. In the group I, Class II elastics will be attached from the maxillary canine to the mandibular first molar bilaterally with passive lingual arch in the lower arch as anchorage means.

In the group I, Class II elastics will be attached from the maxillary canine to mandiular miniscrews bilaterally.

For each patient, two CBCT radiographs will be obtained: one preoperatively and another after completion of distalization.

Other names: Passive lingual arch., Mini-screw.

Primary outcomes

  1. Treatment duration

    Time frame: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)

    months

  2. Skeletal changes

    Time frame: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months) ]

    degrees

  3. Dental changes

    Time frame: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)

    degrees

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Carriere Motion Appliance in The Treatment of Class II Malocclusion Using Different Methods of Anchorage Control (Cone Beam Study)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 30, 2022
Registry last updated
Jul 3, 2024

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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