Back to resultsTreatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates
Primary Purpose
Malocclusion, Angle Class II
Status
Recruiting
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Modified Twin-Block Appliance with Clear Plates.
Traditional Twin-Block appliance
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion, Angle Class II
Eligibility Criteria
Inclusion Criteria: - Patients with mixed dentition at age 10.5-13 years. The patient has Skeletal class II malocclusion caused by mandibular retraction ANB > 5, 8 mm >O.J> 5 mm, SNB<78, angle (NSAr) ≥ ° 125 and normal placement of the upper jaw. The patient is willing to accept treatment with a removable device. No previous orthodontic treatment the growth model is within the normal or horizontal maxillary opening angle of 30 >MM or angle of 400 > Björk patients do not have an upper alveolar dental protrusion. Exclusion Criteria: -Patients with periodontal disease. patients with a neuromuscular disorder. patients of class I or III of malocclusion. Patients with temporomandibular joint disorder. Patients with Skeletal open bite. Patients with poor oral and gingival health the presence of a unilateral or bilateral posterior crossbite. patients who have upper jaw stenosis and need to be prepared by expansion before functional treatment. any patient who does not meet one or more of the Inclusion criteria will be removed from the study.
Sites / Locations
- Hama UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
: Modified Twin-Block Appliance with Clear Plates.
Traditional Twin-Block appliance
Arm Description
Clear plates technique A group of patients in which participants will be undergo to clear plates treatment will be applied to the upper and lower arch 17 hours daily Experimental : Modified Twin-Block Appliance with Clear Plates.
Traditional Twin-Block appliance A group of patients in which participants will undergo to the Traditional Twin-Block appliance Treatment, appliances will be applied to the upper and lower arch 17 hours daily
Outcomes
Primary Outcome Measures
Change in the SNA angle[
This angle the represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
change in the SNB angle [
This angle the represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
change in the mandibular length
Amount of distance measured from the Co point to Gn point in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
change in overjet
Represents The distance between the most anterior point on the lower incisor to the most anterior point on the upper incisor in the cephalometric analysis.
change in the vertical position of incisors
The vertical distance from the edge of the lower incisor to the mandibular plane.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05950581
Brief Title
Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates
Official Title
Treatment Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates VS Traditional Twin Block
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2023 (Anticipated)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hama University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with skeletal class II malocclusion who have a retracted lower jaw will be treated in this study. The efficacy of clear Plates in the treatment of Skeletal Class II Malocclusion will be assessed. The skeletal, dental and soft tissues changes resulted by this intervention will be studied and compared with the results of Traditional treatment with fixed appliances.
Detailed Description
There are two group:
a group of patients in which participants will be undergo to Modified Twin-Block Appliance with Clear Plates.
a group of patients in which participants will be undergo to the traditional Twin-Block Appliance.
phase Intervention/treatment Condition or disease
Not applicable Other:
Modified Twin-Block Appliance with Clear Plates.
Other:
Traditional Twin-Block Appliance. Skeletal class II Malocclusion
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class II
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
: Modified Twin-Block Appliance with Clear Plates.
Arm Type
Experimental
Arm Description
Clear plates technique A group of patients in which participants will be undergo to clear plates treatment will be applied to the upper and lower arch 17 hours daily Experimental : Modified Twin-Block Appliance with Clear Plates.
Arm Title
Traditional Twin-Block appliance
Arm Type
Experimental
Arm Description
Traditional Twin-Block appliance A group of patients in which participants will undergo to the Traditional Twin-Block appliance Treatment, appliances will be applied to the upper and lower arch 17 hours daily
Intervention Type
Device
Intervention Name(s)
Modified Twin-Block Appliance with Clear Plates.
Intervention Description
Clear plates technique A group of patients in which participants will be undergo to clear plates treatment will be applied to the upper and lower arch 17 hours daily
Intervention Type
Device
Intervention Name(s)
Traditional Twin-Block appliance
Intervention Description
Traditional Twin-Block appliance A group of patients in which participants will undergo to the Traditional Twin-Block appliance Treatment, appliances will be applied to the upper and lower arch 17 hours daily
Primary Outcome Measure Information:
Title
Change in the SNA angle[
Description
This angle the represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Time Frame
: T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6-9 months in the exp. Group and control group)
Title
change in the SNB angle [
Description
This angle the represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Time Frame
: T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6-9 months in the exp. Group and control group)
Title
change in the mandibular length
Description
Amount of distance measured from the Co point to Gn point in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Time Frame
T0: 1day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6-9 months in the exp. Group and control group)
Title
change in overjet
Description
Represents The distance between the most anterior point on the lower incisor to the most anterior point on the upper incisor in the cephalometric analysis.
Time Frame
T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6-9 months in the exp. Group and control group)
Title
change in the vertical position of incisors
Description
The vertical distance from the edge of the lower incisor to the mandibular plane.
Time Frame
: T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6-9 months in the exp. Group and control group)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Patients with mixed dentition at age 10.5-13 years.
The patient has Skeletal class II malocclusion caused by mandibular retraction ANB > 5, 8 mm >O.J> 5 mm, SNB<78, angle (NSAr) ≥ ° 125 and normal placement of the upper jaw.
The patient is willing to accept treatment with a removable device.
No previous orthodontic treatment
the growth model is within the normal or horizontal maxillary opening angle of 30 >MM or angle of 400 > Björk
patients do not have an upper alveolar dental protrusion.
Exclusion Criteria:
-Patients with periodontal disease.
patients with a neuromuscular disorder.
patients of class I or III of malocclusion.
Patients with temporomandibular joint disorder.
Patients with Skeletal open bite.
Patients with poor oral and gingival health
the presence of a unilateral or bilateral posterior crossbite.
patients who have upper jaw stenosis and need to be prepared by expansion before functional treatment.
any patient who does not meet one or more of the Inclusion criteria will be removed from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fadi Jnaid
Phone
988499015
Email
Drfadijnaid@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fadi Jnaid
Email
fadijnaid@hama-univ.edu.sy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabab Alsabbagh,, DDS MSc PhD
Organizational Affiliation
Professor of Orthodontics, University of Hama Dental School, Hama, Syria.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
ANAS FAKHOURI
Organizational Affiliation
Student in Orthodontics, University of Hama Dental School, Hama.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hama University
City
Hama
Country
Syrian Arab Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fadi Jnaid
Phone
988499015
Email
Drfadijnaid@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8181550
Citation
Buschang PH, Stroud J, Alexander RG. Differences in dental arch morphology among adult females with untreated Class I and Class II malocclusion. Eur J Orthod. 1994 Feb;16(1):47-52. doi: 10.1093/ejo/16.1.47.
Results Reference
background
PubMed Identifier
3422118
Citation
Clark WJ. The twin block technique. A functional orthopedic appliance system. Am J Orthod Dentofacial Orthop. 1988 Jan;93(1):1-18. doi: 10.1016/0889-5406(88)90188-6. No abstract available.
Results Reference
background
PubMed Identifier
16679196
Citation
Cozza P, Baccetti T, Franchi L, De Toffol L, McNamara JA Jr. Mandibular changes produced by functional appliances in Class II malocclusion: a systematic review. Am J Orthod Dentofacial Orthop. 2006 May;129(5):599.e1-12; discussion e1-6. doi: 10.1016/j.ajodo.2005.11.010.
Results Reference
background
PubMed Identifier
23201327
Citation
de Lira Ade L, de Moura WL, Artese F, Bittencourt MA, Nojima LI. Surgical prediction of skeletal and soft tissue changes in treatment of Class II. J Craniomaxillofac Surg. 2013 Apr;41(3):198-203. doi: 10.1016/j.jcms.2012.07.009. Epub 2012 Nov 30.
Results Reference
background
PubMed Identifier
19852643
Citation
Jung MH, Yang WS, Nahm DS. Maximum closing force of mentolabial muscles and type of malocclusion. Angle Orthod. 2010 Jan;80(1):72-9. doi: 10.2319/020509-78.1.
Results Reference
background
PubMed Identifier
10629520
Citation
Trenouth MJ. Cephalometric evaluation of the Twin-block appliance in the treatment of Class II Division 1 malocclusion with matched normative growth data. Am J Orthod Dentofacial Orthop. 2000 Jan;117(1):54-9. doi: 10.1016/s0889-5406(00)70248-4.
Results Reference
background
PubMed Identifier
2220695
Citation
Tulloch JF, Medland W, Tuncay OC. Methods used to evaluate growth modification in Class II malocclusion. Am J Orthod Dentofacial Orthop. 1990 Oct;98(4):340-7. doi: 10.1016/S0889-5406(05)81491-X.
Results Reference
background
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Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates
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