Class III MalocclusionNCT06762418
Treating Growing Patients With Mandibular Prognathism and Maxillary Constriction
A study testing RMR+SME and BAIMT+RME in people with Class III Malocclusion, run by Damascus University at 2 sites in Syria.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Class III Malocclusion
- What is being tested?
- RMR+SME and BAIMT+RME
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesSyria
- Study dates
- 15 Sep 2021to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- growing male and female patients aged between 12 and 15 years
- Angle's class III malocclusion
- skeletal class III relationship judged clinically and confirmed radiographically (-4 < ANB < + 1)
- 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
- normal inclination of the lower incisors or slightly proclined (i.e., the IMPA between 85° and 100°
- maxillary constriction requiring expansion judged clinically and confirmed radiographically
- permanent dentition
- no previous orthodontic treatment
Who cannot join
- skeletal class III malocclusion caused predominantly by maxillary deficiency (SNA<78° with a normal SNB angle)
- severe skeletal class III presenting mainly due to mandibular protrusion (ANB < - 4° with no functional shift on closure)
- contraindications for the use of the mini-screws, such as osteoporosis (addressed with cortisone and its derivatives) or those undergoing radiation treatment
- a convergence between the mandibular canine root and the first premolar root ,which was assessed radiographically
- facial asymmetry, characterized by a mandibular midline deviation exceeding 2 mm from the facial midline
- MM angle >35° or SN-MP angle > 40°
- The existence of cleft lip or craniofacial syndromes and/or palate abnormalities and
- The existence of supernumerary teeth or missing ones except for the third molars.
Trial locations and contacts
2 sites in 1 country.
Syria2 sites
Adib Al-Lahham Center, Damascus Health Directorate, Ministry of Health
Damascus, DJ223QX
Department of Orthodontics, Faculty of Dentistry, University of Damsacus
Damascus, DM20 HAJ72
About this study
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
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.
- Conditions
- Class III Malocclusion
- Being tested
- RMR+SME, BAIMT+RME
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RMR+SMEDevice
Patients will be asked to wear this removable appliance for 16 hours daily. The expansion screw is activated twice a week.
BAIMT+RMEDevice
The elastics are worn 18 hours per day to achieve the sagittal correction. The RME appliance on the upper jaw is activated twice daily until the required expansion is achieved.
| Study group | Role | What they receive |
|---|---|---|
| RMR with SME | Experimental | The removable mandibular retractor (RMR) will inhibit mandibular growth. This appliance will be supplemented with a medline screw that is used for slow maxillary expansion (SME). Receives: Device: RMR+SME |
| BAIMT with RME | Active comparator | Bone-anchored intermaxillary traction (BAIMT) will be used for Class III correction.
This upper part of the appliance is used for rapid maxillary expansion (RME). Receives: Device: BAIMT+RME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the SNA angle
This angle represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Measured: 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
Change in the SNB angle
his angle represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Measured: 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
Change in the ANB angle
This angle represents the relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Measured: 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
Change in the SN-GoMe angle
This angle represents the position of the lower jaw in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Measured: 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
Change in the MM angle
This angle represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Measured: 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
Change in the SN-SPP angle
This angle represents the position of the upper jaw (represented by the spinal plane "SPP") in the vertical direction of the cephalometric analysis. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Measured: 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
Change in the Witz appraisal
Witz appraisal is measured by the anteroposterior distance between the projections of Points A and B onto the functional occlusal plane, measured in mm. It gives an idea about the sagittal relationship between the upper and lower jaws.
Measured: 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
Change in the Co.Go.Me angle
This angle is created by the intersection between the ramus plane (Co.Go) and the mandibular plane (Go.Me). This is called the gonial angle.
Measured: 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
Change in the mandibular length
This distance is measured between the mandibular condyle (Co) and the genial point (Gn).
Measured: 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
Change in the ramus height
This distance is measured between the mandibular condyle (Co) and mandibular gonial angle (Go).
Measured: 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
Change in the lower facial height
This distance is measured between the anterior nasal spine (ANS) and the lower point on the mandibular symphysis (Me).
Measured: 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
Change in the A-H variable
This variable is the horizontal distance between A point (the maxillary bone point) and the perpendicular plane to the S-N plane through Point S (Sella).
Measured: 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
Change in the B-H variable
This variable is the horizontal distance between B point (the mandibular bone point) and the perpendicular plane to the S-N plane through Point S (Sella).
Measured: 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
Change in the SN-U1
This angle represents the relationship of the upper anterior teeth with SN in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle is going to be measured in degrees.
Measured: 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
Change in the GoMe-L1 angle
This angle represents the relationship of the lower anterior teeth with the mandibular plane in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Measured: 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
Change in the SPP-U1 angle
This angle represents the relationship of the upper anterior teeth with the SPP plane in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Measured: 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
Change in ls-E Line distance
It is the distance between Ricketts's esthetic line and the upper lip point.
Measured: 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
Change in li-E Line distance
It is the distance between the lower lip point and esthetic line of Ricketts.
Measured: 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
Change in the Gla-Sn-Pog angle
It is the angle between the soft tissue forehead point (Gla) and the subnasal point (Sn) and the most anterior point on the soft tissue chin (Pog).
Measured: 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
Change in the naso-labial angle
It is the angle between the upper lip and nasal columella plane.
Measured: 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
Change in the labio-mental angle
It is the angle between the lower lip and the chin. It is also called the labio-mental fold angle..
Measured: 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
Change in the Ag to MZF-j variable
Maxillomandibular width right: measured from the Jugal process to the frontofacial plane. This measurement is measured on the frontal cephalogram.
Measured: 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
Change in the J-J distance
It is the maxillary width measured on the frontal cephalogram.
Measured: 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
Change in the molar width at the level of apices (M-MRA)
This is measured between the apices of the palatal roots of the maxillary first molars (R.RA-L.RA) on the frontal cephalogram.
Measured: 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
Change in the molar width at the level of cusps (M-MCT)
This is measured between the mesio-palatal cusps tips of the maxillary first molars (R.CT-L.CT) on the frontal cephalogram.
Measured: 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
Change in the inferred molar tipping (M-tip)
The difference between R.RA-L.RA and R.CT-L.CT variables mentioned above and the difference is given in mm.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start15 Sep 2021
- Primary completion15 Jan 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Class III MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Sains Malaysia
- Responsible party
- Sponsor
- Investigators
- Mohammad Younis Hajeer, DDS MSc PhD, Study director, Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762418
- Sponsor's protocol ID
- UDDS-Ortho-1-2025
- Status last verified
- Mar 2025
- First submitted
- 31 Dec 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27443361Saleh 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.
PubMed 23758461Saleh 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.
PubMed 23323964Rabah 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.
PubMed 36108265Rabah 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.
PubMed 35261839
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06762418
- Acronym / sponsor ID
- UDDS-Ortho-1-2025
- Conditions
- Class III Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Collaborators
- Universiti Sains Malaysia
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RMR with SME | Experimental | Device: RMR+SMEThe removable mandibular retractor (RMR) will inhibit mandibular growth. This appliance will be supplemented with a medline screw that is used for slow maxillary expansion (SME). |
| BAIMT with RME | Active comparator | Device: BAIMT+RMEBone-anchored intermaxillary traction (BAIMT) will be used for Class III correction. This upper part of the appliance is used for rapid maxillary expansion (RME). |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- growing male and female patients aged between 12 and 15 years
- Angle's class III malocclusion
- skeletal class III relationship judged clinically and confirmed radiographically (-4 < ANB < + 1)
- 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
- normal inclination of the lower incisors or slightly proclined (i.e., the IMPA between 85° and 100°
Key exclusion criteria (8 listed)
- skeletal class III malocclusion caused predominantly by maxillary deficiency (SNA<78° with a normal SNB angle)
- severe skeletal class III presenting mainly due to mandibular protrusion (ANB < - 4° with no functional shift on closure)
- contraindications for the use of the mini-screws, such as osteoporosis (addressed with cortisone and its derivatives) or those undergoing radiation treatment
- a convergence between the mandibular canine root and the first premolar root ,which was assessed radiographically
- facial asymmetry, characterized by a mandibular midline deviation exceeding 2 mm from the facial midline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RMR+SMEPatients will be asked to wear this removable appliance for 16 hours daily. The expansion screw is activated twice a week. | Device | RMR with SME |
| BAIMT+RMEThe elastics are worn 18 hours per day to achieve the sagittal correction. The RME appliance on the upper jaw is activated twice daily until the required expansion is achieved. | Device | BAIMT with RME |
Primary outcome
Change in the SNA angle
Time frame: 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
This angle represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Change in the SNB angle
Time frame: 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
his angle represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Change in the ANB angle
Time frame: 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
This angle represents the relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Change in the SN-GoMe angle
Time frame: 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
This angle represents the position of the lower jaw in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Change in the MM angle
Time frame: 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
This angle represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Change in the SN-SPP angle
Time frame: 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
This angle represents the position of the upper jaw (represented by the spinal plane "SPP") in the vertical direction of the cephalometric analysis. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Change in the Witz appraisal
Time frame: 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
Witz appraisal is measured by the anteroposterior distance between the projections of Points A and B onto the functional occlusal plane, measured in mm. It gives an idea about the sagittal relationship between the upper and lower jaws.
Change in the Co.Go.Me angle
Time frame: 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
This angle is created by the intersection between the ramus plane (Co.Go) and the mandibular plane (Go.Me). This is called the gonial angle.
Change in the mandibular length
Time frame: 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
This distance is measured between the mandibular condyle (Co) and the genial point (Gn).
Change in the ramus height
Time frame: 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
This distance is measured between the mandibular condyle (Co) and mandibular gonial angle (Go).
Change in the lower facial height
Time frame: 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
This distance is measured between the anterior nasal spine (ANS) and the lower point on the mandibular symphysis (Me).
Change in the A-H variable
Time frame: 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
This variable is the horizontal distance between A point (the maxillary bone point) and the perpendicular plane to the S-N plane through Point S (Sella).
Change in the B-H variable
Time frame: 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
This variable is the horizontal distance between B point (the mandibular bone point) and the perpendicular plane to the S-N plane through Point S (Sella).
Change in the SN-U1
Time frame: 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
This angle represents the relationship of the upper anterior teeth with SN in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle is going to be measured in degrees.
Change in the GoMe-L1 angle
Time frame: 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
This angle represents the relationship of the lower anterior teeth with the mandibular plane in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Change in the SPP-U1 angle
Time frame: 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
This angle represents the relationship of the upper anterior teeth with the SPP plane in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken, and this angle will be measured in degrees.
Change in ls-E Line distance
Time frame: 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
It is the distance between Ricketts's esthetic line and the upper lip point.
Change in li-E Line distance
Time frame: 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
It is the distance between the lower lip point and esthetic line of Ricketts.
Change in the Gla-Sn-Pog angle
Time frame: 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
It is the angle between the soft tissue forehead point (Gla) and the subnasal point (Sn) and the most anterior point on the soft tissue chin (Pog).
Change in the naso-labial angle
Time frame: 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
It is the angle between the upper lip and nasal columella plane.
Change in the labio-mental angle
Time frame: 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
It is the angle between the lower lip and the chin. It is also called the labio-mental fold angle..
Change in the Ag to MZF-j variable
Time frame: 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
Maxillomandibular width right: measured from the Jugal process to the frontofacial plane. This measurement is measured on the frontal cephalogram.
Change in the J-J distance
Time frame: 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
It is the maxillary width measured on the frontal cephalogram.
Change in the molar width at the level of apices (M-MRA)
Time frame: 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
This is measured between the apices of the palatal roots of the maxillary first molars (R.RA-L.RA) on the frontal cephalogram.
Change in the molar width at the level of cusps (M-MCT)
Time frame: 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
This is measured between the mesio-palatal cusps tips of the maxillary first molars (R.CT-L.CT) on the frontal cephalogram.
Change in the inferred molar tipping (M-tip)
Time frame: 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
The difference between R.RA-L.RA and R.CT-L.CT variables mentioned above and the difference is given in mm.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Background: PubMed 27443361Majanni 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.
- Background: PubMed 23758461Saleh 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.
- Background: PubMed 23323964Saleh 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.
- Background: PubMed 36108265Rabah 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.
- Background: PubMed 35261839Rabah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Younis Hajeer, DDS MSc PhD study director
Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RMR+SME and BAIMT+RME in people with Class III Malocclusion, run by Damascus University at 2 sites in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the SNA angle (time frame: 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). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06762418, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.