An interventional study of Mini-implant-supported Twin-Block and Twin-Block in Orthodontic Appliance Complication and Malocclusion, Angle Class II, Division 1, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 10 Years to 13 Years. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
Correcting the skeletal class II using functional appliances, whether removable or fixed, always leads to skeletal and alveolar effects. However, some of these effects are unfavorable, the most significant being the loss of support in the lower dental arch. This loss of support leads to an uncontrolled labial inclination of the lower incisors and mesial movement of the lower; these dentoalveolar effects impact the degree of skeletal correction that can be achieved. Therefore, this study aimed to evaluate the skeletal and dentoalveolar effects following the use of a mini-implant-supported Twin-Block appliance compared to the conventional Twin-Block.
Many attempts have been made to modify the Twin-Block appliance to decrease the dentoalveolar effects, such as omitting the upper labial bow, including torquing spurs on the upper incisors, and adding acrylic capping on the lower incisors. However, these modifications have not been successful in eliminating the dentoalveolar effects. This is because the Twin-Block and other functional appliances are supported by teeth rather than bone. As a result, the components of the appliance exert force on the teeth while the mandible attempts to return to its natural resting position. No previous clinical trial described the use of the Twin-Block appliance supported by orthodontic mini-implants and the potential benefits of using mini-implants with Twin-Block in functional treatment.
124 studies on the registry are indexed under Malocclusion, Angle Class II; 19 are open to participants now.
This study's enrollment of 41 is above the median of 34 across 115 interventional studies indexed under Malocclusion, Angle Class II.
Browse Malocclusion, Angle Class II studies →Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Treatment will be done using the Mini-implant-supported Twin-block appliance until the correction is achieved.
Device: Mini-implant-supported Twin-Block
Treatment will be done using the Twin-block appliance until the correction is achieved.
Device: Twin-Block
Mini-implants will support the Twin-Block appliance during the functional treatment.
This is the main appliance that will be used to correct the Class II deformity.
Change in the overjet
Lateral cephalometric images were taken for each patient. This was measured sagittally from the upper central incisor edge to the labial surface of the lower central incisor (in mm).
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the overbite
Lateral cephalometric images were taken for each patient. This was measured vertically from the upper to the lower central incisors' edges (in mm).
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the molar relationship
Lateral cephalometric images were taken for each patient. This was measured sagittally from the mesial cusp of the maxillary first permanent molar to the mesial cusp of the mandibular first permanent molar (in mm).
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the position of the maxillary base
Lateral cephalometric images were taken for each patient. This was measured sagittally from A point to a vertical reference plane (in mm).
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the position of the mandibular base
Lateral cephalometric images were taken for each patient. This was measured sagittally from Pogonion Point to a vertical reference plane (in mm).
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the mandibular position relative to the upper jaw
Lateral cephalometric images were taken for each patient. This was measured sagittally from A point to Pogonion Point (in mm).
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in condylar head position
Lateral cephalometric images were taken for each patient. This was measured sagittally from Condylion point to the vertical reference plane (in mm).
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the composite mandibular length
Lateral cephalometric images were taken for each patient. This was measured sagittally from Condylion Point to the Pogonion Point (in mm).
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in position of the maxillary incisor
Lateral cephalometric images were taken for each patient. This was measured sagittally from the upper central incisor edge to the A Point (in mm).
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in position of the mandibular incisor
Lateral cephalometric images were taken for each patient. This was measured sagittally from the lower central incisor edge to the Pogonion Point (in mm).
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in position of the maxillary permanent first molar
Lateral cephalometric images were taken for each patient. This was measured sagittally from the mesial cusp of the maxillary first permanent molar to A Point (in mm).
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in position of the mandibular permanent first molar
Lateral cephalometric images were taken for each patient. This was measured sagittally from the mesial cusp of the mandibular first permanent molar to the Pogonion Point (in mm).
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the ramus height
Lateral cephalometric images were taken for each patient. The distance was measured vertically from the Articular Point (Ar) to the Gonion Point (Go) in millimeters.
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the corpus length
Lateral cephalometric images were taken for each patient. This was measured sagittally from the Gonion (Go) Point to the Mention (Me) Point. The distance is measured in mm.
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in MM angle
Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. It is calculated for the internal angle formed by the intersection between the maxillary and mandibular planes.
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the SN-OP
Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the relationship between the occlusal plane (OP) and the anterior cranial base (the distance between Sella (S) and Nasion (N)) in the vertical direction.
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the SN-MP
Lateral cephalometric images were taken for each patient This angle, measured in degrees, represented the relationship between the lower jaw plane and the cranial base in the vertical direction.
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the Bjork sum (N-S-Ar + S-Ar-Go +Ar-Go-Me)
Lateral cephalometric images were taken for each patient. This angle, measured in degrees, was the sum of three angles: the saddle angle (N-S-Ar angle), the articular angle (S-Ar-Go), and the gonial angle (Ar-Go-Me).
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the inclination of the upper incisors.
Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the relationship between the upper incisor axis and the anterior cranial base in the anteroposterior direction. It was measured between the upper incisor axis and the SN plane.
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the L1-MP angle
Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the relationship between the lower incisor axis and the mandibular base in the anteroposterior direction. It was measured between the lower incisor axis and the Go-Me plane.
Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Plan to share: No
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Malocclusion, Angle Class II →