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

NCT05418413 | Completed DMC

• 1 other identifier: UDDS-Ortho-12-2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Class II Malocclusion

Keywords

Class II; Twin Block; Functional Therapy

Outcome Measures

Primary Outcomes (3)

• Dentoskeletal mandible changes as measured by tomographic

  changes of the mandible before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs

  Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1).

• Lower incisor angle changes

  Lower incisor angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.

  Changes will be evaluated before treatment and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1)

• ANB angle changes

  ANB angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.

  Changes will be evaluated before treatment and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1)

Secondary Outcomes (9)

• Dentoskeletal maxilla changes as measured by tomographic superimposition of the cranial base

  Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1)

• SNA angle changes

  Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1)

• SNB angle changes

  Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1).

• Soft tissue changes

  Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1)

• The duration of functional treatment

  After obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months

Study Arms (2)

Conventional Twin-block appliance

ACTIVE COMPARATOR

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

Device: CTB

Esthetic Twin-block appliance

EXPERIMENTAL

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

Device: ETB

Interventions

CTB 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.

Conventional Twin-block appliance

ETB 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

Esthetic Twin-block appliance

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

University of Damascus

Damascus, Syria

Location

Related Publications (7)

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

  PMID: 16254470 BACKGROUND

• 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.

  PMID: 32637187 BACKGROUND

• 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.

  PMID: 10935956 BACKGROUND

• 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.

  PMID: 32904097 BACKGROUND

• 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.

  PMID: 28128634 BACKGROUND

• 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.

  PMID: 41152368 DERIVED

• 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.

  PMID: 39805909 DERIVED

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class II; Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mohammed Najati Alsilq, DDS

  Department of orthodontics, Damascus University, Syria

  PRINCIPAL INVESTIGATOR

• Mohamed Youssef, DDS,MSc,PhD

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

  STUDY DIRECTOR

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: June 10, 2022
• First Posted: June 14, 2022
• Study Start: December 28, 2021
• Primary Completion: September 30, 2022
• Study Completion: February 28, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)