Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates

Malocclusion, Angle Class II Clinical Trial

Official title:

Treatment Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates VS Traditional Twin Block

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05950581
• Other study ID #: Hama University -Orthdontic.
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: July 15, 2024

Study information

• Verified date: September 2023
• Source: Hama University
• Contact: Fadi Jnaid
• Phone: 988499015
• Email: Drfadijnaid[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

There are two group: 1. a group of patients in which participants will be undergo to Modified Twin-Block Appliance with Clear Plates. 2. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: July 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class II

Intervention

Device:
• Modified Twin-Block Appliance with Clear Plates.
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
• Traditional Twin-Block appliance
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

Locations

Country	Name	City	State
Syrian Arab Republic	Hama University	Hama

Sponsors (1)

Lead Sponsor	Collaborator
Hama University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	: 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)
Primary	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.	: 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)
Primary	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.	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)
Primary	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.	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)
Primary	change in the vertical position of incisors	The vertical distance from the edge of the lower incisor to the mandibular plane.	: 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)