Clinical trial NCT05418413: The Use of an Esthetic Twin Block for Patients With Mandibular Retrusion
Official title: Dentoskeletal Changes Resulting From Treatment of Skeletal Class II With an Esthetic Twin Block Appliance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class II Malocclusion
Keywords: Class II
Twin Block
Functional Therapy
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 50
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Dentoskeletal mandible changes as measured by tomographic
timeFrame: 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).
measure: Lower incisor angle changes
timeFrame: 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)
measure: ANB angle changes
timeFrame: 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:
measure: Dentoskeletal maxilla changes as measured by tomographic superimposition of the cranial base
timeFrame: 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)
measure: SNA angle changes
timeFrame: 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)
measure: SNB angle changes
timeFrame: 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).
measure: Soft tissue changes
timeFrame: 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)
measure: The duration of functional treatment
timeFrame: 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
measure: Levels of pain
timeFrame: 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.
measure: Levels of discomfort
timeFrame: 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.
measure: Levels of acceptance
timeFrame: 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.
measure: Number of broken appliances
timeFrame: During the treatment time which will take approximately 8 months.
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: University of Damascus
Study officials:
affiliation: Department of orthodontics, Damascus University, Syria
name: Mohammed Najati Alsilq, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Orthodontics, University of Damascus, Dental School, Damascus, Syria.
name: Mohamed Youssef, DDS,MSc,PhD
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.
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.
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.