Clinical trial NCT06762418: Treating Growing Patients With Mandibular Prognathism and Maxillary Constriction
Official title: Radiographic Analysis of Skeletal and Dentoalveolar Changes Following the Treatment of Mandibular Prognathism and Maxillary Constriction in Growing Patients Using Two Different Treatment Protocols: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class III Malocclusion
Lead sponsor: Damascus University
Sponsor class: OTHER
Collaborators: name: Universiti Sains Malaysia
First posted: 2025-01-07
Enrollment: 26
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial intends to test the efficacy of two treatment protocols in the correction of Class III malocclusion with maxillary constriction. We have to options, either to modify the growth using inter-maxillary traction based on an upper fixed appliance that is used in the same time for rapid maxillary expansion or to inhibit mandibular growth by a removable mandibular retractor (RMR) supplied with an expansion screw.


Eligibility criteria: Inclusion Criteria:

1. growing male and female patients aged between 12 and 15 years
2. Angle's class III malocclusion
3. skeletal class III relationship judged clinically and confirmed radiographically (-4 \< ANB \< + 1)
4. An anterior crossbite involving two or more teeth or an edge-to-edge incisor relationship with or without an anterior shift of the lower jaw upon closure
5. normal inclination of the lower incisors or slightly proclined (i.e., the IMPA between 85° and 100°
6. maxillary constriction requiring expansion judged clinically and confirmed radiographically
7. permanent dentition
8. no previous orthodontic treatment

Exclusion Criteria:

1. skeletal class III malocclusion caused predominantly by maxillary deficiency (SNA\<78° with a normal SNB angle)
2. severe skeletal class III presenting mainly due to mandibular protrusion (ANB \< - 4° with no functional shift on closure)
3. contraindications for the use of the mini-screws, such as osteoporosis (addressed with cortisone and its derivatives) or those undergoing radiation treatment
4. a convergence between the mandibular canine root and the first premolar root ,which was assessed radiographically
5. facial asymmetry, characterized by a mandibular midline deviation exceeding 2 mm from the facial midline
6. MM angle \>35° or SN-MP angle \> 40°
7. The existence of cleft lip or craniofacial syndromes and/or palate abnormalities and
8. The existence of supernumerary teeth or missing ones except for the third molars.

Primary outcomes:
measure: Change in the SNA angle
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the SNB angle
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the ANB angle
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the SN-GoMe angle
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the MM angle
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the SN-SPP angle
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the Witz appraisal
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the Co.Go.Me angle
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the mandibular length
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the ramus height
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the lower facial height
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the A-H variable
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the B-H variable
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the SN-U1
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the GoMe-L1 angle
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the SPP-U1 angle
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in ls-E Line distance
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in li-E Line distance
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the Gla-Sn-Pog angle
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the naso-labial angle
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the labio-mental angle
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the Ag to MZF-j variable
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the J-J distance
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the molar width at the level of apices (M-MRA)
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the molar width at the level of cusps (M-MCT)
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
measure: Change in the inferred molar tipping (M-tip)
timeFrame: At two assessment times: (1) one day before the beginning of the treatment, and (2) at the end of the retention phase which is expected to occur within 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Adib Al-Lahham Center, Damascus Health Directorate, Ministry of Health
city: Damascus
country: Syrian Arab Republic
facility: Department of Orthodontics, Faculty of Dentistry, University of Damsacus
Study officials:
affiliation: Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
name: Mohammad Younis Hajeer, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Rabah N, Al-Ibrahim HM, Hajeer MY, Ajaj MA. Evaluation of rapid versus slow maxillary expansion in early adolescent patients with skeletal maxillary constriction using cone-beam computed tomography: A short-term follow-up randomized controlled trial. Dent Med Probl. 2022 Oct-Dec;59(4):583-591. doi: 10.17219/dmp/133513.
citation: 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.