Evaluation of the Skeletal and Dentoalveolar Effects of Mini-implant-supported Twin-Block in Treating Growing Patients With Class II Division 1 Malocclusion: A Two-arm Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Damascus University
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Change in the SN-MP
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 10 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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),
- •lower second molars erupting.
Exclusion Criteria
- •Previous orthodontic procedures.
- •Systemic diseases.
- •Temporal Mandibular Joint disorders.
- •Poor oral hygiene
Arms & Interventions
Mini-implant-supported Twin-Block
Treatment will be done using the Mini-implant-supported Twin-block appliance until the correction is achieved.
Intervention: Mini-implant-supported Twin-Block (Device)
Conventional Twin-Block group
Treatment will be done using the Twin-block appliance until the correction is achieved.
Intervention: Twin-Block (Device)
Outcomes
Primary Outcomes
Change in the SN-MP
Time Frame: 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)
Time Frame: 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.
Time Frame: 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
Time Frame: 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 mandibular position relative to the upper jaw
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 overbite
Time Frame: 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 position of the maxillary base
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
No secondary outcomes reported