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Mini-implant-supported Twin-Block in Treating Patients With Class II Division 1 Malocclusion

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06403033
Enrollment
41
Registered
2024-05-07
Start date
2022-09-10
Completion date
2023-12-26
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion, Angle Class II, Division 1, Orthodontic Appliance Complication

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.

Interventions

DEVICEMini-implant-supported 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.

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 13 Years
Healthy volunteers
No

Inclusion criteria

1. The wrist radiograph (stage 4 S and stage 5 MP3 cap) 2. Skeletal Class II division 1 malocclusion caused by mandibular retrusion 3. ANB (5°- 9°) 4. SNB (72°- 77°) 5. overjet (5 - 8 mm), 6. Minimal crowding in dental arches (≤ 3 mm), 7. MM≤30° 8. lower second molars erupting.

Exclusion criteria

1. Previous orthodontic procedures. 2. Systemic diseases. 3. Temporal Mandibular Joint disorders. 4. Poor oral hygiene

Design outcomes

Primary

MeasureTime frameDescription
Change in the overjetT0: 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 overbiteT0: 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 molar relationshipT0: 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 position of the maxillary baseT0: 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 the position of the mandibular baseT0: 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 mandibular position relative to the upper jawT0: 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 condylar head positionT0: 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 lengthT0: 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 incisorT0: 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 incisorT0: 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 position of the maxillary permanent first molarT0: 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 molarT0: 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 ramus heightT0: 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 corpus lengthT0: 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 angleT0: 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.
Change in the SN-OPT0: 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 SN-MPT0: 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 angleT0: 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.

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026