Clinical Trials/NCT06596239

NCT06596239

Completed

Not Applicable

Hard- and Soft-tissue Changes Following Class III Treatment With the Lower-Clear-Plate-Based Intermaxillary Traction Versus the Removable Mandibular Retractor: a Two-arm Randomized Controlled Clinical Trial

Damascus University1 site in 1 country30 target enrollmentJune 15, 2023

ConditionsClass III Malocclusion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Class III Malocclusion
Sponsor: Damascus University
Enrollment: 30
Locations: 1
Primary Endpoint: Change in the SNA angle
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Detailed 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.

Registry

clinicaltrials.gov

Start Date

June 15, 2023

End Date

June 15, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Damascus University

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in the SNA angle

Time Frame: Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group

Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction.

Change in the SNB angle

Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction.

Change in the ANB angle

Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction.

Change in the S.N.Pog angle

Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the position of the chin in the cephalometric analysis in the anteroposterior direction.

Change in the SN-MaxP angle

Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the upper jaw plane and the cranial base in the vertical direction of cephalometric analysis.

Change in the SN-ManP angle

Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the lower jaw plane and the cranial base in the vertical direction of cephalometric analysis.

Change in the MaxP.ManP angle

Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis.

Change in the Bjork sum (NS-Ar + S-Ar-Go +Ar-Go-Me)

Lateral cephalometric images were taken for each patient, and this angle was measured in degrees.

Change in the Wits appraisal

Lateral cephalometric images were taken for each patient. This was measured millimetres horizontally from the projection of points A (AO) and B (BO) along the functional occlusal plane.

Change in the U1.SN angle

Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the upper central incisor axis and the cranial base in the anteroposterior direction of cephalometric analysis.

Change in the L1-GoMe angle

Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the lower central incisor axis and the mandibular plane in the anteroposterior direction of cephalometric analysis.

Change in the overbite (Ovb)

Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the upper to the lower central incisors.

Change in the overjet (Ovj)

Lateral cephalometric images were taken for each patient. This was measured millimetres Horizontally from the upper to the lower central incisors.

Secondary Outcomes

Change in the Soft tissue convexity angle(Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group)
Change in the Ls-Esth measurement(Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group)
Change in the Li-Esth measurement(Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group)
Change in the Nasolabial angle(Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group)
Change in the Mento-labial angle(Time 1: one day before the start of treatment; Time 2: one day after the end of active treatment which is expected to occur within three months in the LCP-IMT group and five months in the RMR group)