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

Dentoskeletal Changes Resulting From Treatment of Skeletal Class II With an Esthetic Twin Block Appliance.

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.

Study Overview

• Status: Completed
• Conditions: Class II Malocclusion
• Intervention / Treatment: Device: CTB; Device: ETB

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammad Y Hajeer, DDS,MSc,PhD; Phone Number: +963940404840; Email: myhajeer@gmail.com

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic
    • University of Damascus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Twin-block appliance; The patients in this control group will be treated using the conventional Twin-block appliance (CTB).	Device: 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.
Experimental: Esthetic Twin-block appliance; the patients in this experimental group will be treated using the esthetic Twin-block appliance (ETB).	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dentoskeletal maxilla changes as measured by tomographic superimposition of the cranial base	changes of the maxilla 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)
SNA angle changes	SNA angle changes 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)
SNB angle changes	SNB angle changes 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).
Soft tissue changes	Soft tissue changes before and after treatment will be assessed and compared with those of the control group (Facial convexity angle, Nasolabial angle, Z-Merrifield angle, …etc) using profile photography.	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	The duration of the functional treatment will be measured and compared between groups.	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
Levels of pain	The level of pain will be assessed and compared with those of the control group using a questionnaire with a Visual Analog Scale (VAS). The VAS is a 10-cm horizontal line with two focal points at its beginning and end (0: there is no pain - 10: the worst pain).	A questionnaire will be given to the patients five times during treatment; after 1 week, after 1 week, after 6 weeks, after 3 months and at the end of the application of the appliance.
Levels of discomfort	The level of discomfort will be assessed and compared with those of the control group using a questionnaire with a Visual Analog Scale (VAS). The VAS is a 10-cm horizontal line with two focal points at its beginning and end (0: there is no discomfort - 10: the worst discomfort).	A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 6 weeks, after 3 months and at the end of the application of the appliance.
Levels of acceptance	The level of acceptance will be assessed and compared with those of the control group using a questionnaire with a Visual Analog Scale (VAS). The VAS is a 10-cm horizontal line with two focal points at its beginning and end (0: no acceptance - 10: the best acceptance).	A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 6 weeks, after 3 months and at the end of the application of the appliance.
Number of broken appliances	The number of broken will be counted and compared with those of the control group .	During the treatment time which will take approximately 8 months.

Collaborators and Investigators

• Sponsor: Damascus University

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Class II; Twin Block; Functional Therapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: UDDS-Ortho-12-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No