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

D

Damascus University

Status

Completed

Conditions

Class III Malocclusion

Treatments

Device: lower-clear-plate-based intermaxillary traction (LCP-IMT)
Device: Removable mandibular retractor (RMR)

Study type

Interventional

Funder types

Other

Identifiers

NCT06596239
UDDS-Ortho-4-2024

Details and patient eligibility

About

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).

Full description

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.

Enrollment

30 patients

Sex

All

Ages

9 to 13 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Lower-clear-plate-based intermaxillary traction (LCP-IMT)
Experimental group
Description:
Patients in this group will be treated using the LCP-IMT technique.
Treatment:
Device: lower-clear-plate-based intermaxillary traction (LCP-IMT)
Removable mandibular retractor (RMR)
Active Comparator group
Description:
Patients in this group will be treated using the RMR appliance.
Treatment:
Device: Removable mandibular retractor (RMR)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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