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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Malocclusion, Angle Class II
• Intervention / Treatment: Device: Modified Twin-Block Appliance with Clear Plates.; Device: Traditional Twin-Block appliance

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fadi Jnaid; Phone Number: 988499015; Email: Drfadijnaid@gmail.com
• Study Contact Backup: Name: Fadi Jnaid; Email: fadijnaid@hama-univ.edu.sy

Study Locations

• Syria
  • Hama, Syria
    • Recruiting
    • Hama University
    • Contact: Fadi Jnaid; Phone Number: 988499015; Email: Drfadijnaid@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: : 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 Experimental : Modified Twin-Block Appliance with Clear Plates.	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
Experimental: 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	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Hama University
• Investigators: Study Director: Rabab Alsabbagh,, DDS MSc PhD, Professor of Orthodontics, University of Hama Dental School, Hama, Syria.; Principal Investigator: ANAS FAKHOURI, Student in Orthodontics, University of Hama Dental School, Hama.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Fritz JD, Utz AL, Hale NM, Wu L, Powers AC, Verdoorn TA, Robertson D. Gene-based neurotransmitter modulation in cerebellar granule neurons. J Neurochem. 1997 Jan;68(1):204-12. doi: 10.1046/j.1471-4159.1997.68010204.x.

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II
• Other Study ID Numbers: Hama University -Orthdontic.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No