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

Not Applicable

Completed

• Conditions: Class III Malocclusion
• Interventions: Device: lower-clear-plate-based intermaxillary traction (LCP-IMT); Device: Removable mandibular retractor (RMR)

• Registration Number: NCT06596239
• Lead Sponsor: Damascus University

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.

Study Timeline

• Study Start: 2023-06-15
• Primary Completion: 2024-03-15
• Study Completion: 2024-06-15
• Status Verified: 2024-09
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-11
• Last Update Submitted: 2024-09-11
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lower-clear-plate-based intermaxillary traction (LCP-IMT)	lower-clear-plate-based intermaxillary traction (LCP-IMT)	Patients in this group will be treated using the LCP-IMT technique.
Removable mandibular retractor (RMR)	Removable mandibular retractor (RMR)	Patients in this group will be treated using the RMR appliance.

Primary Outcome Measures

Name	Time	Method
Change in the SNA 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	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	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 lower jaw in the cephalometric analysis in the anteroposterior direction.
Change in the ANB 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	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	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 chin in the cephalometric analysis in the anteroposterior direction.
Change in the SN-MaxP 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	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	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 relationship between the lower jaw plane and the cranial base in the vertical direction of cephalometric analysis.
Change in the MaxP.ManP 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	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)	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.
Change in the Wits appraisal	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. 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	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 relationship between the upper central incisor axis and the cranial base in the anteroposterior direction of cephalometric analysis.
Change in the L1-GoMe 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	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)	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. This was measured in millimetres vertically from the upper to the lower central incisors.
Change in the overjet (Ovj)	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. This was measured millimetres Horizontally from the upper to the lower central incisors.

Secondary Outcome Measures

Name	Time	Method
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	Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle is to evaluate the profile of the face. It is formed by the intersection of two lines: one from the glabella (the area between the eyebrows) to the subnasale (the point where the nose meets the upper lip), and another from the subnasale to the pogonion (the most forward point on the chin in the cephalometric analysis in the anteroposterior direction.
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	Lateral cephalometric images were taken for each patient. This was measured in millimetres from the Labrale superius and E-Line of Ricketts.
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	Lateral cephalometric images were taken for each patient. This was measured in millimetres from the Labrale inferius and E-Line of Ricketts.
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	Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the nose and the upper lip in the cephalometric analysis in the anteroposterior direction.
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	Lateral cephalometric images were taken for each patient, and this angle was measured in degrees. This angle represents the relationship between the chin and the lower lip in the cephalometric analysis in the anteroposterior direction.

Trial Locations

Locations (1)

Department of Orthodontics, Faculty of Dentistry, University of Damsacus; 🇸🇾 Damascus, Syrian Arab Republic