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Completed

NCT Number: NCT06762418

Treating Growing Patients With Mandibular Prognathism and Maxillary Constriction

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.

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Key information

Conditions

Class III Malocclusion Malocclusion Malocclusion, Angle Class III Stomatognathic Diseases Tooth Diseases

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adib Al-Lahham Center, Damascus Health Directorate, Ministry of Health, Damascus, Syria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

RMR+SME

Device

Patients will be asked to wear this removable appliance for 16 hours daily. The expansion screw is activated twice a week.

BAIMT+RME

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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).

  20. 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.

  21. 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..

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Collaborators

  • Universiti Sains Malaysia

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 7, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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