Mini-implant-supported Twin-Block in Treating Patients With Class II Division 1 Malocclusion
- Conditions
- Malocclusion, Angle Class II, Division 1Orthodontic Appliance Complication
- Interventions
- Device: Mini-implant-supported Twin-BlockDevice: Twin-Block
- Registration Number
- NCT06403033
- Lead Sponsor
- Damascus University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- The wrist radiograph (stage 4 S and stage 5 MP3 cap)
- Skeletal Class II division 1 malocclusion caused by mandibular retrusion
- ANB (5°- 9°)
- SNB (72°- 77°)
- overjet (5 - 8 mm),
- Minimal crowding in dental arches (≤ 3 mm),
- MM≤30°
- lower second molars erupting.
- Previous orthodontic procedures.
- Systemic diseases.
- Temporal Mandibular Joint disorders.
- Poor oral hygiene
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mini-implant-supported Twin-Block Mini-implant-supported Twin-Block Treatment will be done using the Mini-implant-supported Twin-block appliance until the correction is achieved. Conventional Twin-Block group Twin-Block Treatment will be done using the Twin-block appliance until the correction is achieved.
- Primary Outcome Measures
Name Time Method Change in the SN-MP T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. 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.
Change in the Bjork sum (N-S-Ar + S-Ar-Go +Ar-Go-Me) T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. 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).
Change in the inclination of the upper incisors. T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. 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.
Change in the L1-MP angle T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. 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.
Change in the overbite T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. Lateral cephalometric images were taken for each patient. This was measured vertically from the upper to the lower central incisors' edges (in mm).
Change in the mandibular position relative to the upper jaw T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. Lateral cephalometric images were taken for each patient. This was measured sagittally from A point to Pogonion Point (in mm).
Change in position of the maxillary permanent first molar T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. 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).
Change in position of the mandibular permanent first molar T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. 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).
Change in the SN-OP T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. 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.
Change in the position of the mandibular base T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. Lateral cephalometric images were taken for each patient. This was measured sagittally from Pogonion Point to a vertical reference plane (in mm).
Change in the position of the maxillary base T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. Lateral cephalometric images were taken for each patient. This was measured sagittally from A point to a vertical reference plane (in mm).
Change in condylar head position T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. Lateral cephalometric images were taken for each patient. This was measured sagittally from Condylion point to the vertical reference plane (in mm).
Change in the composite mandibular length T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. Lateral cephalometric images were taken for each patient. This was measured sagittally from Condylion Point to the Pogonion Point (in mm).
Change in position of the maxillary incisor T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. Lateral cephalometric images were taken for each patient. This was measured sagittally from the upper central incisor edge to the A Point (in mm).
Change in position of the mandibular incisor T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. Lateral cephalometric images were taken for each patient. This was measured sagittally from the lower central incisor edge to the Pogonion Point (in mm).
Change in the ramus height T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. 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.
Change in the overjet T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. 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).
Change in the molar relationship T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. 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).
Change in the corpus length T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. 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.
Change in MM angle T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Orthodontics, Faculty of Dentistry, University of Damsacus
🇸🇾Damascus, Syrian Arab Republic