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

Class II Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05418413
• Other study ID #: UDDS-Ortho-12-2022
• Status: Completed
• Phase: N/A
• Start date: December 28, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: April 2023
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 28, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Class II Malocclusion
• Malocclusion
• Malocclusion, Angle Class II

Intervention

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.
• 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

Locations

Country	Name	City	State
Syrian Arab Republic	University of Damascus	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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).
Secondary	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)
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.