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

Primary Purpose

Class II Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
CTB
ETB
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Malocclusion focused on measuring Class II, Twin Block, Functional Therapy

Eligibility Criteria

11 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Damascus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Twin-block appliance

Esthetic Twin-block appliance

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
The duration of functional treatment
The duration of the functional treatment will be measured and compared between groups.
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).
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).
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).
Number of broken appliances
The number of broken will be counted and compared with those of the control group .

Full Information

First Posted
June 10, 2022
Last Updated
April 5, 2023
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05418413
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 28, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Malocclusion
Keywords
Class II, Twin Block, Functional Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Twin-block appliance
Arm Type
Active Comparator
Arm Description
The patients in this control group will be treated using the conventional Twin-block appliance (CTB).
Arm Title
Esthetic Twin-block appliance
Arm Type
Experimental
Arm Description
the patients in this experimental group will be treated using the esthetic Twin-block appliance (ETB).
Intervention Type
Device
Intervention Name(s)
CTB
Intervention Description
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
Intervention Name(s)
ETB
Intervention Description
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
Primary Outcome Measure Information:
Title
Dentoskeletal mandible changes as measured by tomographic
Description
changes of the mandible before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs
Time Frame
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).
Title
Lower incisor angle changes
Description
Lower incisor angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Time Frame
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)
Title
ANB angle changes
Description
ANB angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Time Frame
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 Measure Information:
Title
Dentoskeletal maxilla changes as measured by tomographic superimposition of the cranial base
Description
changes of the maxilla before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Time Frame
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)
Title
SNA angle changes
Description
SNA angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Time Frame
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)
Title
SNB angle changes
Description
SNB angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.
Time Frame
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).
Title
Soft tissue changes
Description
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.
Time Frame
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)
Title
The duration of functional treatment
Description
The duration of the functional treatment will be measured and compared between groups.
Time Frame
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
Title
Levels of pain
Description
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).
Time Frame
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.
Title
Levels of discomfort
Description
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).
Time Frame
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.
Title
Levels of acceptance
Description
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).
Time Frame
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.
Title
Number of broken appliances
Description
The number of broken will be counted and compared with those of the control group .
Time Frame
During the treatment time which will take approximately 8 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Najati Alsilq, DDS
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Youssef, DDS,MSc,PhD
Organizational Affiliation
Professor of Orthodontics, University of Damascus, Dental School, Damascus, Syria.
Official's Role
Study Director
Facility Information:
Facility Name
University of Damascus
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16254470
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.
Results Reference
background
PubMed Identifier
32637187
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.
Results Reference
background
PubMed Identifier
10935956
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.
Results Reference
background
PubMed Identifier
32904097
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.
Results Reference
background
PubMed Identifier
28128634
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.
Results Reference
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The Use of an Esthetic Twin Block for Patients With Mandibular Retrusion

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