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

NCT06403033 | Completed DMC

• 1 other identifier: UDDS-Ortho-3-2024
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (20)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Mini-implant-supported Twin-Block

EXPERIMENTAL

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

Device: Mini-implant-supported Twin-Block

Conventional Twin-Block group

ACTIVE COMPARATOR

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

Device: Twin-Block

Interventions

Mini-implant-supported Twin-Block DEVICE

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

Mini-implant-supported Twin-Block

Twin-Block DEVICE

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

Conventional Twin-Block group

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Previous orthodontic procedures.
• Systemic diseases.
• Temporal Mandibular Joint disorders.
• Poor oral hygiene

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, University of Damsacus

Damascus, DM20 HAJ72, Syria

Location

Related Publications (6)

• 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.

  PMID: 35345811 BACKGROUND

• 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.

  PMID: 25296729 BACKGROUND

• 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.

  PMID: 30837435 BACKGROUND

• 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.

  PMID: 12970656 BACKGROUND

• 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.

  PMID: 25052373 BACKGROUND

• Ghareeb RA, Sultan K, Hajeer MY, Ajaj MA, Alzoubi H. Comparison of skeletal and dentoalveolar effects of mini-implant-supported twin block versus conventional twin block in treating growing patients with Class II Division 1 malocclusion: a two-arm randomized controlled clinical trial. Eur J Orthod. 2025 Oct 16;47(6):cjaf093. doi: 10.1093/ejo/cjaf093.

  PMID: 41347939 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Rabea A Ghareeb, DDS

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

  PRINCIPAL INVESTIGATOR

• Kinda Sultan, DDS MSc PhD

  Department of Orthodontics, Faculty of Dentistry, Damascus University

  STUDY DIRECTOR

• Mohammad Y Hajeer, DDS MSc PhD

  Department of Orthodontics, Faculty of Dentistry, Damascus University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: September 10, 2022
• Primary Completion: November 27, 2023
• Study Completion: December 26, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)