NCT05631353

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

November 21, 2022

Last Update Submit

July 2, 2024

Conditions

Keywords

Carriere Motion Appliance

Outcome Measures

Primary Outcomes (3)

  • Treatment duration

    months

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

  • Skeletal changes

    degrees

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

  • Dental changes

    degrees

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

Study Arms (2)

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

ACTIVE COMPARATOR

Conventional mandibular anchorage During the first month, 1/4-inch heavy elastics will be used. In the following months, 3/16-inch heavy elastics will be used. The patients will be instructed to wear the elastics 24 hours per day, except during mealtimes, and to change them daily

Device: Carriere Motion Appliance

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

ACTIVE COMPARATOR

TADs mandibular anchorage. During the first month, 1/4-inch heavy elastics will be used. In the following months, 3/16-inch heavy elastics will be used. The patients will be instructed to wear the elastics 24 hours per day, except during mealtimes, and to change them daily

Device: Carriere Motion Appliance

Interventions

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.

Also known as: Passive lingual arch., Mini-screw.
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.

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alazhar university

Asyut, Egypt

Location

Related Publications (3)

  • Carriere L. A new Class II distalizer. J Clin Orthod. 2004 Apr;38(4):224-31. No abstract available.

    PMID: 15115896BACKGROUND
  • Rodriguez HL. Unilateral application of the Carriere Distalizer. J Clin Orthod. 2011 Mar;45(3):177-80. No abstract available.

    PMID: 21785202BACKGROUND
  • Wilson B, Konstantoni N, Kim KB, Foley P, Ueno H. Three-dimensional cone-beam computed tomography comparison of shorty and standard Class II Carriere Motion appliance. Angle Orthod. 2021 Jul 1;91(4):423-432. doi: 10.2319/041320-295.1.

    PMID: 33560300BACKGROUND

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class IIMalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • Saleh Anwar El-sayed, professor

    saleh.anwar@azhar.edu.eg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
data will be sent blinded for statistical analysis
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

November 21, 2022

First Posted

November 30, 2022

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

April 1, 2024

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations