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

NCT06596239 | Completed DMC

• 1 other identifier: UDDS-Ortho-4-2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Class III Malocclusion

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (5)

• 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

Study Arms (2)

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

EXPERIMENTAL

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

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

Removable mandibular retractor (RMR)

ACTIVE COMPARATOR

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

Device: Removable mandibular retractor (RMR)

Interventions

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

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

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

Removable mandibular retractor (RMR) DEVICE

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

Removable mandibular retractor (RMR)

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, University of Damsacus

Damascus, DM20 HAJ72, Syria

Location

Related Publications (5)

• 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.

  PMID: 37008891 BACKGROUND

• 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.

  PMID: 9674678 BACKGROUND

• 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.

  PMID: 23323964 BACKGROUND

• 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.

  PMID: 27443361 BACKGROUND

• 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.

  PMID: 9699409 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mohammad Younis Hajeer

  Yes

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: June 15, 2023
• Primary Completion: March 15, 2024
• Study Completion: June 15, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)