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

Orthodontic Appliance Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06403033
• Other study ID #: UDDS-Ortho-3-2024
• Status: Completed
• Phase: N/A
• Start date: September 10, 2022
• Est. completion date: December 26, 2023

Study information

• Verified date: May 2024
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 26, 2023
• Est. primary completion date: November 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Mini-implant-supported Twin-Block
Mini-implants will support the Twin-Block appliance during the functional treatment.
• Twin-Block
This is the main appliance that will be used to correct the Class II deformity.

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Orthodontics, Faculty of Dentistry, University of Damsacus	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

Abdulhadi A, Burhan AS, Hajeer MY, Hamadah O, Mahmoud G, Nawaya FR, Namera MO. Evaluation of the Functional Treatment of Patients With Skeletal Class II Malocclusion Using Low-Level Laser Therapy-Assisted Twin-Block Appliance: A Three-Arm Randomized Controlled Trial. Cureus. 2022 Mar 24;14(3):e23449. doi: 10.7759/cureus.23449. eCollection 2022 Mar. — View Citation

Burhan AS, Nawaya FR. Dentoskeletal effects of the Bite-Jumping Appliance and the Twin-Block Appliance in the treatment of skeletal Class II malocclusion: a randomized controlled trial. Eur J Orthod. 2015 Jun;37(3):330-7. doi: 10.1093/ejo/cju052. Epub 2014 Oct 8. — View Citation

Ehsani S, Nebbe B, Normando D, Lagravere MO, Flores-Mir C. Short-term treatment effects produced by the Twin-block appliance: a systematic review and meta-analysis. Eur J Orthod. 2015 Apr;37(2):170-6. doi: 10.1093/ejo/cju030. Epub 2014 Jul 22. — View Citation

O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I. Effectiveness of early orthodontic treatment with the Twin-block appliance: a multicenter, randomized, controlled trial. Part 1: Dental and skeletal effects. Am J Orthod Dentofacial Orthop. 2003 Sep;124(3):234-43; quiz 339. doi: 10.1016/S0889540603003524. — View Citation

Tripathi T, Singh N, Rai P, Gupta P. Mini-implant-supported twin-block appliance: An innovative modification. Niger J Clin Pract. 2019 Mar;22(3):432-438. doi: 10.4103/njcp.njcp_342_18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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).	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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).	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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).	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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).	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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).	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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).	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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).	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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).	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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).	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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).	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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).	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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.	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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.	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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.	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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.	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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.	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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).	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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.	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Primary	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.	T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.