Evaluating the Effectiveness of the Lower-Clear-Plate-Based Intermaxillary Traction

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2024-06-15

Brief Summary

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Patients at the Orthodontic Department of the University of Damascus Dental School will be examined, and subjects who meet the inclusion criteria will be included. Then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, and radiographic images) will be studied to ensure the selection criteria are accurately matched.

This study compares two groups of patients with mild to moderate skeletal Class III in the late mixed occlusion stage. Experimental group: the patients in this group will be treated with Lower-Clear-Plate Based Intermaxillary Traction Control group: the patients in this group will be treated using the Removable Mandibular Retractor (RMR).

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Detailed Description

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There are different methods of correcting Class III deformity in Orthodontics. Lower-clear-plate-based intermaxillary traction has been shown to be an effective method of managing these cases. This treatment modality has not been compared with the well-known appliance (the removable mandibular retractor; RMR). Therefore, the current study compares both groups of growing children with Class III malocclusion. The study design is a randomized controlled trial.

Conditions

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Class III Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lower-clear-plate-based intermaxillary traction (LCP-IMT)

Patients in this group will be treated using the LCP-IMT technique.

Group Type EXPERIMENTAL

lower-clear-plate-based intermaxillary traction (LCP-IMT)

Intervention Type DEVICE

The patient is instructed to apply elastics between the upper molar bands and the hooks on the lower clear plates.

Removable mandibular retractor (RMR)

Patients in this group will be treated using the RMR appliance.

Group Type ACTIVE_COMPARATOR

Removable mandibular retractor (RMR)

Intervention Type DEVICE

An appliance is worn on the upper jaw, which affects the lower jaw by using an inferiorly extended labial bow.

Interventions

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lower-clear-plate-based intermaxillary traction (LCP-IMT)

The patient is instructed to apply elastics between the upper molar bands and the hooks on the lower clear plates.

Intervention Type DEVICE

Removable mandibular retractor (RMR)

An appliance is worn on the upper jaw, which affects the lower jaw by using an inferiorly extended labial bow.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Class III dental malocclusion at the molar relationship, according to Angle's classification
* Presence of an anterior crossbite on two or more teeth or an edge-to-edge relationship at the anterior teeth
* Mild to moderate skeletal Class III in the late mixed occlusion stage (9-13 years old) or the beginning of permanent occlusion (not exceeding 13 years old; ANB = +1 to -4 degrees)
* Normal or horizontal growth pattern (MM ≤ 35; SN.ManP ≤ 40)
* Normal or labial inclination of the lower incisors (IMPA = 85 to 100 degrees)
* Patient's willingness to cooperate during the orthodontic treatment period

Exclusion Criteria

* Class III skeletal relationship caused solely by the maxillary recession (SNA \< 78 and a normal SNB angle)
* An indication of RME
* Presence of clear asymmetry (deviation of mandibular midline more than 2 mm from facial midline)
* Presence of any craniofacial syndromes (such as cleft lip or palate)
* Systemic diseases; previous facial trauma; and Previous orthodontic treatment.

Minimum Eligible Age

9 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No