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

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

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).

Study Overview

• Status: Completed
• Conditions: Class III Malocclusion
• Intervention / Treatment: Device: lower-clear-plate-based intermaxillary traction (LCP-IMT); Device: 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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic, DM20 HAJ72
    • Department of Orthodontics, Faculty of Dentistry, University of Damsacus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the SNA angle	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.	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 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.	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 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.	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 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.	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 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.	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 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.	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 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.	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 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.	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 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.	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 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.	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 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.	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 overbite (Ovb)	Lateral cephalometric images were taken for each patient. This was measured in millimetres vertically from the upper to the lower central incisors.	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 overjet (Ovj)	Lateral cephalometric images were taken for each patient. This was measured millimetres Horizontally from the upper to the lower central incisors.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Soft tissue convexity angle	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.	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	Lateral cephalometric images were taken for each patient. This was measured in millimetres from the Labrale superius and E-Line of Ricketts.	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	Lateral cephalometric images were taken for each patient. This was measured in millimetres from the Labrale inferius and E-Line of Ricketts.	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	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.	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	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.	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

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Study Chair: Mohammad Younis Hajeer, yes

Publications and helpful links

General Publications

• Husson AH, Burhan AS, Hajeer MY, Nawaya FR. Evaluation of the dimensional changes in the mandible, condyles, and the temporomandibular joint following skeletal class III treatment with chin cup and bonded maxillary bite block using low-dose computed tomography: A single-center, randomized controlled trial. F1000Res. 2023 Mar 13;12:264. doi: 10.12688/f1000research.130941.1. eCollection 2023.
• Garattini G, Levrini L, Crozzoli P, Levrini A. Skeletal and dental modifications produced by the Bionator III appliance. Am J Orthod Dentofacial Orthop. 1998 Jul;114(1):40-4. doi: 10.1016/s0889-5406(98)70235-5.
• Saleh M, Hajeer MY, Al-Jundi A. Short-term soft- and hard-tissue changes following Class III treatment using a removable mandibular retractor: a randomized controlled trial. Orthod Craniofac Res. 2013 May;16(2):75-86. doi: 10.1111/ocr.12007. Epub 2012 Nov 8.
• Majanni AM, Hajeer MY. The Removable Mandibular Retractor vs the Bone-anchored Intermaxillary Traction in the Correction of skeletal class III Malocclusion in children: A Randomized Controlled Trial. J Contemp Dent Pract. 2016 May 1;17(5):361-71. doi: 10.5005/jp-journals-10024-1856.
• Baccetti T, Tollaro I. A retrospective comparison of functional appliance treatment of Class III malocclusions in the deciduous and mixed dentitions. Eur J Orthod. 1998 Jun;20(3):309-17. doi: 10.1093/ejo/20.3.309.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): June 15, 2024

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 11, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 11, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Malocclusion; Prognathism; Malocclusion, Angle Class III
• Other Study ID Numbers: UDDS-Ortho-4-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No