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

NCT ID: NCT06403033

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-10
• Study Completion Date: 2023-12-26

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mini-implant-supported Twin-Block

Treatment will be done using the Mini-implant-supported Twin-block appliance until the correction is achieved.

Group Type: EXPERIMENTAL

Mini-implant-supported Twin-Block

Intervention Type: DEVICE

Mini-implants will support the Twin-Block appliance during the functional treatment.

Conventional Twin-Block group

Treatment will be done using the Twin-block appliance until the correction is achieved.

Group Type: ACTIVE_COMPARATOR

Twin-Block

Intervention Type: DEVICE

This is the main appliance that will be used to correct the Class II deformity.

Interventions

Mini-implant-supported Twin-Block

Mini-implants will support the Twin-Block appliance during the functional treatment.

Intervention Type: DEVICE

Twin-Block

This is the main appliance that will be used to correct the Class II deformity.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damascus University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rabea A Ghareeb, DDS

Role: PRINCIPAL_INVESTIGATOR

Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

Kinda Sultan, DDS MSc PhD

Role: STUDY_DIRECTOR

Department of Orthodontics, Faculty of Dentistry, Damascus University

Mohammad Y Hajeer, DDS MSc PhD

Role: STUDY_CHAIR

Department of Orthodontics, Faculty of Dentistry, Damascus University

Locations

Department of Orthodontics, Faculty of Dentistry, University of Damsacus

Damascus, , Syria

Countries

Syria

References

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.

Reference Type: BACKGROUND

PMID: 35345811 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25296729 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30837435 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12970656 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25052373 (View on PubMed)

Other Identifiers

UDDS-Ortho-3-2024

Identifier Type: -

Identifier Source: org_study_id