The Use of an Esthetic Twin Block for Patients With Mandibular Retrusion

NCT ID: NCT05418413

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-28
• Study Completion Date: 2023-02-28

Brief Summary

This experimental study will evaluate the effect of an esthetic Twin-block appliance on the correction of class II malocclusion compared with the traditional Twin-block appliance.

The study sample will consist of 50 patients with class II malocclusion. The sample will be allocated randomly into two groups: the control group and the experimental group.

The traditional Twin-block appliance will be applied for the control group patients, while the esthetic Twin-block appliance will be applied for the experimental group patients. The dentoskeletal, soft tissue changes and esthetic and functional efficacy occurring after functional treatment will be assessed using cephalometric radiographs and profile photographs, pre and post-treatment, and a questionnaire. Changes for each group will be evaluated individually, and the two groups will be compared.

Detailed Description

Class II malocclusion is one of the most frequent orthodontic problems, and most class II malocclusion cases are the result of mandibular deficiency. Twin block (TB) is one of the most popular functional appliances to treat this condition. Despite excellent treatment results with TB, its acceptance and compliance may be hampered by its wiry structure and appearance. Furthermore, it has a side effect of causing the proclination of lower incisors, which reduces skeletal change. Various modifications were proposed to reduce lower incisors proclination but had no significant effect. Patient cooperation is one of the most important factors for successful functional appliance treatment, and it depends upon comfort and esthetic acceptability, which ensures good patient compliance. so, in order to enhance the esthetic appearance and overcome the disadvantages of a conventional Twin-Block (CTB), a novel esthetic Twin-Block (ETB) was fabricated from a specific material using a pressure molding device and acrylic bite blocks. There is only one study that evaluated this appliance which is a pilot study that compared the treatment effects of the (ETB) and (CTB) in the treatment of Class II malocclusions. However, this study has a lot of limitations, making it difficult to evaluate this appliance's efficiency accurately. The aim of this study is to study the dento-skeletal, soft tissue changes, and esthetic and functional efficacy that result from treatment by this appliance (ETB) and to compare them to the changes in the matched group will be treated with (CTB), by studying the cephalometric radiographs, profile photographs, and a questionnaire.

Conditions

Class II Malocclusion

Study Design

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

Study Groups

Conventional Twin-block appliance

The patients in this control group will be treated using the conventional Twin-block appliance (CTB).

Group Type: ACTIVE_COMPARATOR

CTB

Intervention Type: DEVICE

conventional Twin-block (CTB) will be comprised of maxillary and mandibular removable appliances having the labial bows, adam's clasps, and with no incisal capping.

Esthetic Twin-block appliance

the patients in this experimental group will be treated using the esthetic Twin-block appliance (ETB).

Group Type: EXPERIMENTAL

ETB

Intervention Type: DEVICE

will be comprised of maxillary and mandibular removable 1.5-mm biocryl sheet will be adapted separately on maxillary and mandibular casts with help of vacuum machine, and Acrylic bite blocks with the inclined plane will be fabricated on biocryl sheets sim

Interventions

CTB

conventional Twin-block (CTB) will be comprised of maxillary and mandibular removable appliances having the labial bows, adam's clasps, and with no incisal capping.

Intervention Type: DEVICE

ETB

will be comprised of maxillary and mandibular removable 1.5-mm biocryl sheet will be adapted separately on maxillary and mandibular casts with help of vacuum machine, and Acrylic bite blocks with the inclined plane will be fabricated on biocryl sheets sim

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Angle class II malocclusion because of mandibular retrognathia
• O.J > 5 , SNB < 78
• Patient during growth spurt
• Normal or horizontal growth pattern Björk > 402

Exclusion Criteria

• TMJ disorders
• Poor oral hygiene
• Previous orthodontic treatment.
• Patients with syndromes, clefts, or craniofacial abnormalities.
• Reason of contraindication of functional treatment

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damascus University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohammed Najati Alsilq, DDS

Role: PRINCIPAL_INVESTIGATOR

Department of orthodontics, Damascus University, Syria

Mohamed Youssef, DDS,MSc,PhD

Role: STUDY_DIRECTOR

Professor of Orthodontics, University of Damascus, Dental School, Damascus, Syria.

Locations

University of Damascus

Damascus, , Syria

Countries

Syria

References

Sidlauskas A. Clinical effectiveness of the Twin block appliance in the treatment of Class II Division 1 malocclusion. Stomatologija. 2005;7(1):7-10.

Reference Type: BACKGROUND

PMID: 16254470 (View on PubMed)

Tripathi T, Singh N, Rai P, Gupta P. Comparison of Dentoskeletal Changes, Esthetic, and Functional Efficacy of Conventional and Novel Esthetic Twin Block Appliances among Class II Growing Patients: A Pilot Study. Turk J Orthod. 2020 Jun 1;33(2):77-84. doi: 10.5152/TurkJOrthod.2020.19030. eCollection 2020 Jun.

Reference Type: BACKGROUND

PMID: 32637187 (View on PubMed)

Baccetti T, Franchi L, Toth LR, McNamara JA Jr. Treatment timing for Twin-block therapy. Am J Orthod Dentofacial Orthop. 2000 Aug;118(2):159-70. doi: 10.1067/mod.2000.105571.

Reference Type: BACKGROUND

PMID: 10935956 (View on PubMed)

Shahamfar M, Atashi MHA, Azima N. Soft Tissue Esthetic Changes Following a Modified Twin Block Appliance Therapy: A Prospective Study. Int J Clin Pediatr Dent. 2020 May-Jun;13(3):255-260. doi: 10.5005/jp-journals-10005-1759.

Reference Type: BACKGROUND

PMID: 32904097 (View on PubMed)

van der Plas MC, Janssen KI, Pandis N, Livas C. Twin Block appliance with acrylic capping does not have a significant inhibitory effect on lower incisor proclination. Angle Orthod. 2017 Jul;87(4):513-518. doi: 10.2319/102916-779.1. Epub 2017 Jan 27.

Reference Type: BACKGROUND

PMID: 28128634 (View on PubMed)

Alsilq MN, Youssef M. Soft tissue effects of aesthetic and conventional twin block appliances in the treatment of skeletal class II malocclusion: a randomized controlled trial. Sci Rep. 2025 Oct 28;15(1):37627. doi: 10.1038/s41598-025-21538-w.

Reference Type: DERIVED

PMID: 41152368 (View on PubMed)

Alsilq MN, Youssef M. Dentoskeletal effects of aesthetic and conventional twin block appliances in the treatment of skeletal class II malocclusion: a randomized controlled trial. Sci Rep. 2025 Jan 13;15(1):1879. doi: 10.1038/s41598-025-86219-0.

Reference Type: DERIVED

PMID: 39805909 (View on PubMed)

Other Identifiers

UDDS-Ortho-12-2022

Identifier Type: -

Identifier Source: org_study_id