TADs Anchored vs Conventional Anchored Carriere Motion Appliance

NCT ID: NCT05631353

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-04-01

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Class II Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
data will be sent blinded for statistical analysis

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

Carriere Motion Appliance

Intervention Type 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.

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

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

Group Type ACTIVE_COMPARATOR

Carriere Motion Appliance

Intervention Type 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.

Interventions

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Carriere Motion Appliance

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.

Intervention Type DEVICE

Other Intervention Names

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Passive lingual arch. Mini-screw.

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Abdelshafy Ali

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saleh Anwar El-sayed, professor

Role: STUDY_CHAIR

[email protected]

Locations

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Alazhar university

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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

Reference Type BACKGROUND
PMID: 15115896 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 21785202 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33560300 (View on PubMed)

Other Identifiers

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Carriere motion appliance

Identifier Type: -

Identifier Source: org_study_id

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