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| Name | Class |
|---|---|
| Universiti Sains Malaysia | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RMR with SME | Device | The RMR will be used in conjunction with slow maxillary expansion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in speech difficulties | Patients will be asked to identify their perception of speech difficulties by answering, " Do you suffer from speech difficulties 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthodontics, Faculty of Dentistry, University of Damsacus | Damascus | DM20 HAJ72 | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34033675 | Background | 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. | |
| 35261839 | 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. |
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| ID | Term |
|---|---|
| D008313 | Malocclusion, Angle Class III |
| D063173 | Retrognathia |
| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007569 | Jaw Abnormalities |
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| BAIMT with RME | Device | The bone-anchored intermaxillary traction will be used with rapid maxillary expansion |
|
| 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 | Patients will be asked to identify their perception of swallowing disability by answering, " Do you suffer from a swallowing disability 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 limitation in the movement of the mandible. | Patients will be asked to identify their perception of limitation in the movement of the mandible by answering, "Do you suffer from a limitation in the movement of the mandible 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 feeling of embarrassment | Patients will be asked to identify their shame by asking, " Do you feel ashamed 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. |
| 23758461 | 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. |
| 29857794 | 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. |
| 9825554 | 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. |
| 41040030 | Derived | 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. |
| D007571 |
| Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D008336 | Mandibular Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |