Evaluation of Pain and Functional Impairments When Treating Class III Malocclusion Using Two Treatment Procedures

NCT ID: NCT06877780

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-09-01

Brief Summary

A clinical examination of each recalled candidate patient will be carried out at Adib Al Lahham Centre at the Ministry of Health Damascus to ensure that he/she meets the inclusion criteria. Following obtaining the full records, including a lateral cephalometric radiograph, additional checking will be made to classify the skeletal relationship (class III relationship) of each possible candidate for this work.

This trial compares two groups of patients who suffered from Class III malocclusion associated with maxillary constriction.

Experimental Group: Patients in this group will undergo treatment using bone-anchored intermaxillary traction (BAIMT) associated with rapid maxillary expansion (RME).

Control Group: Patients in this group will undergo treatment using a removable mandibular retractor (RMR) associated with slow maxillary expansion (SME).

Detailed Description

Treating skeletal Class III malocclusion presents challenges. However, various methods have been implemented for treating Class III cases through growth modification during the primary and mixed dentition stages, such as the removable mandibular retractor (RMR) and recently bone-anchored intermaxillary traction (BAIMT) system. In orthodontics, there has been increasing interest in assessing patient-reported outcome measures (PROMs) for two reasons: First, the patient's psychosocial well-being enhances collaboration during treatment. Second, the results of orthodontic treatment may advance if the patient is informed and self-assured regarding their treatment.

Participants will be chosen from patients attending the Adib Al Lahham Centre at the Ministry of Health Damascus. Eligible patients with Class III malocclusion associated with maxillary constriction who meet the inclusion criteria will be asked to participate in this study following a screening conducted by the researcher. Informed consent will be acquired from all patients who consent to participate in the survey after receiving an information sheet.

For BAIMT with the RME group, a modified Hyrax palatal expander with posterior bite planes will be bonded. The expander will also have hooks welded distal to the first molars to attach elastic bands. Two self-drilling mini screws will be inserted buccally between the roots of the mandibular canine and the first premolar. Then, intermaxillary elastics will be placed between the hooks and the mandibular.

FOR RMR with SME group, patients in this group will be provided with an RMR appliance containing a midline split that included an expansion screw, and an anterior sagittal expansion screw which will be utilized when necessary to rectify the upper incisors axes.

A change in the relationship of the incisor from a negative overjet to a positive one (i.e., + 1.5 mm or greater) will be deemed a sign of successful treatment in the sagittal plane. If the defect in the transverse plane is addressed first, the expansion will be halted, and the patient will be asked to keep wearing the appliance until the deficiency in the sagittal plane is corrected. On the other hand, if the defect in the sagittal plane is corrected initially, the process will be reversed.

The levels of pain, functional impairment, and confidence will be self-reported using a questionnaire with a 4-point Likert scale administered at five evaluation times during the first 6 months of treatment initiation.

Conditions

Class III Malocclusion; Maxillary Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Removable mandibular retractor with slow maxillary expansion

Patients in this group will undergo treatment using a removable mandibular retractor (RMR) associated with slow maxillary expansion (SME).

Group Type: ACTIVE_COMPARATOR

RMR with SME

Intervention Type: DEVICE

The RMR will be used in conjunction with slow maxillary expansion

Bone-anchored intermaxillary traction with rapid maxillary expansion

Patients in this group will undergo treatment using bone-anchored intermaxillary traction (BAIMT) associated with rapid maxillary expansion (RME).

Group Type: EXPERIMENTAL

BAIMT with RME

Intervention Type: DEVICE

The bone-anchored intermaxillary traction will be used with rapid maxillary expansion

Interventions

RMR with SME

The RMR will be used in conjunction with slow maxillary expansion

Intervention Type: DEVICE

BAIMT with RME

The bone-anchored intermaxillary traction will be used with rapid maxillary expansion

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Growing patients between the ages of 12-15 of either gender.
• Angle's class III malocclusion.
• Skeletal class III (-4 < ANB < + 1).
• Anterior crossbite involving two or more teeth or edge-to-edge incisor relationship with or without a forward shift of the mandible during closure.
• The incisor mandibular plane's (IMPA) angle should be between 85° and 100°.
• Maxillary constriction necessitates expansion.

Exclusion Criteria

• Skeletal class III malocclusion is mainly caused by maxillary retrognathism.
• Severe skeletal class III, mainly resulting from mandibular prognathism.
• Contraindications for the application of the mini-screws.
• The presence of supernumerary teeth or missing ones except for the third molars.
• The presence of cleft lip or craniofacial syndromes and/or palate abnormalities.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universiti Sains Malaysia

OTHER

Sponsor Role: collaborator

Damascus University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmad S. Zakaria, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Orthodontics, School of Dental Sciences, USM Health Campus, Kelantan, Malaysia

Rozita Hassan, DDS MSc PhD

Role: STUDY_CHAIR

Department of Orthodontics, School of Dental Sciences, USM Health Campus, Kelantan, Malaysia

Locations

Department of Orthodontics, Faculty of Dentistry, University of Damsacus

Damascus, , Syria

Countries

Syria

References

Abed Al Jawad FH, Alhashimi NA. Evaluation of self-perceived pain and jaw function impairment in children undergoing slow and rapid maxillary expansion. Angle Orthod. 2021 Nov 1;91(6):725-732. doi: 10.2319/020221-100.1.

Reference Type: BACKGROUND

PMID: 34033675 (View on PubMed)

Rabah N, Al-Ibrahim HM, Hajeer MY, Ajaj MA, Mahmoud G. Assessment of Patient-Centered Outcomes When Treating Maxillary Constriction Using a Slow Removable Versus a Rapid Fixed Expansion Appliance in the Adolescence Period: A Randomized Controlled Trial. Cureus. 2022 Mar 3;14(3):e22793. doi: 10.7759/cureus.22793. eCollection 2022 Mar.

Reference Type: BACKGROUND

PMID: 35261839 (View on PubMed)

Saleh M, Hajeer MY, Al-Jundi A. Assessment of pain and discomfort during early orthodontic treatment of skeletal Class III malocclusion using the Removable Mandibular Retractor Appliance. Eur J Paediatr Dent. 2013 Jun;14(2):119-24.

Reference Type: BACKGROUND

PMID: 23758461 (View on PubMed)

Ryan FS, Cunningham SJ. Patient-reported outcome measures and orthodontics. J Orthod. 2018 Jun;45(2):63-64. doi: 10.1080/14653125.2018.1472729. No abstract available.

Reference Type: BACKGROUND

PMID: 29857794 (View on PubMed)

Sergl HG, Zentner A. A comparative assessment of acceptance of different types of functional appliances. Eur J Orthod. 1998 Oct;20(5):517-24. doi: 10.1093/ejo/20.5.517.

Reference Type: BACKGROUND

PMID: 9825554 (View on PubMed)

Zakaria AS, Hassan R, Baharin F, Alfailany DT, Hajeer MY, Al-Hamod IA, Al-Sabbagh R. Evaluation of Patient-reported Outcome Measures during the Correction of Skeletal Class III Malocclusion with Maxillary Constriction in Early Adolescence. J Contemp Dent Pract. 2025 Jun 1;26(6):598-607. doi: 10.5005/jp-journals-10024-3901.

Reference Type: DERIVED

PMID: 41040030 (View on PubMed)

Other Identifiers

UDDS-Ortho-5-2025

Identifier Type: -

Identifier Source: org_study_id