An interventional study of RMR+SME and BAIMT+RME in Class III Malocclusion, sponsored by Damascus University. Completed at 2 sites in Syrian Arab Republic. Open to participants aged 12 Years to 15 Years. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
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.
57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.
This study's enrollment of 26 is below the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.
Browse Malocclusion, Angle Class III studies →Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Device: RMR+SME
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).
Device: BAIMT+RME
Patients will be asked to wear this removable appliance for 16 hours daily. The expansion screw is activated twice a week.
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.
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
Change in the mandibular length
This distance is measured between the mandibular condyle (Co) and the genial point (Gn).
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
Change in the ramus height
This distance is measured between the mandibular condyle (Co) and mandibular gonial angle (Go).
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
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).
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
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).
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
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).
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
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.
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
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.
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
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.
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
Change in ls-E Line distance
It is the distance between Ricketts's esthetic line and the upper lip point.
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
Change in li-E Line distance
It is the distance between the lower lip point and esthetic line of Ricketts.
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
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).
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
Change in the naso-labial angle
It is the angle between the upper lip and nasal columella plane.
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
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..
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
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.
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
Change in the J-J distance
It is the maxillary width measured on the frontal cephalogram.
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
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.
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
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.
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
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.
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
Plan to share: No
Ran from Sep 2021 to primary completion in Jan 2023, 16 months.
Of 37 non-industry interventional studies with no phase under Malocclusion, Angle Class III, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's 16 months is above that.
Counting every sponsor, half of 38 studies reached it within 13 months; a quarter within 10 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Malocclusion, Angle Class III →