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

NCT06877780 | Completed DMC

• 1 other identifier: UDDS-Ortho-5-2025
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Class III Malocclusion; Maxillary Deficiency

Outcome Measures

Primary Outcomes (2)

• Change in the feeling of pressure at the soft tissues

  Patients will be asked to identify their pressure at the soft tissues by asking, " Do you suffer from pressure at the soft tissues while wearing the device/applying the elastics?" They will choose their possible answer from one of the following options according to the four-point scale: (1) None (2) mild (3) moderate (4) severe, which corresponds to the following numbers (0-1-2-3).

  The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.

• Change in the perception of pain

  Patients will be asked to identify their pain perception by answering, " Do you suffer from pain while wearing the device/applying the elastics?" They will choose their possible answer from one of the following options according to the four-point scale: (1) None (2) mild (3) moderate (4) severe, which corresponds to the following numbers (0-1-2-3).

  The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.

Secondary Outcomes (4)

• Change in speech difficulties

  The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.

• Change in the swallowing difficulties

  The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.

• Change in the limitation in the movement of the mandible.

  The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.

• Change in the feeling of embarrassment

  The questionnaire will be distributed to the patients at five assessment times: (T1) one day after the active treatment initiation, (T2) after one week (T3) after a month, (T4) after 3 months, and (T5) after 6 months of treatment initiation.

Study Arms (2)

Removable mandibular retractor with slow maxillary expansion

ACTIVE COMPARATOR

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

Device: RMR with SME

Bone-anchored intermaxillary traction with rapid maxillary expansion

EXPERIMENTAL

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

Device: BAIMT with RME

Interventions

RMR with SME DEVICE

The RMR will be used in conjunction with slow maxillary expansion

Removable mandibular retractor with slow maxillary expansion

BAIMT with RME DEVICE

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

Bone-anchored intermaxillary traction with rapid maxillary expansion

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead
• Universiti Sains Malaysia: collaborator

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, University of Damsacus

Damascus, DM20 HAJ72, Syria

Location

Related Publications (6)

• 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.

  PMID: 34033675 BACKGROUND

• 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.

  PMID: 35261839 BACKGROUND

• 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.

  PMID: 23758461 BACKGROUND

• 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.

  PMID: 29857794 BACKGROUND

• 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.

  PMID: 9825554 BACKGROUND

• 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.

  PMID: 41040030 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class III; Retrognathia

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ahmad S. Zakaria, DDS MSc

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

  PRINCIPAL INVESTIGATOR

• Rozita Hassan, DDS MSc PhD

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

  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: March 10, 2025
• First Posted: March 14, 2025
• Study Start: September 1, 2021
• Primary Completion: July 15, 2022
• Study Completion: September 1, 2023
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)