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

NCT05950581 | Recruiting

• 1 other identifier: Hama University -Orthdontic.
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion, Angle Class II

Outcome Measures

Primary Outcomes (5)

• 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)

Study Arms (2)

: Modified Twin-Block Appliance with Clear Plates.

EXPERIMENTAL

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.

Traditional Twin-Block appliance

EXPERIMENTAL

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

Interventions

Modified Twin-Block Appliance with Clear Plates. DEVICE

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

: Modified Twin-Block Appliance with Clear Plates.

Traditional Twin-Block appliance DEVICE

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

Traditional Twin-Block appliance

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hama University: lead

Study Sites (1)

Hama University

Hama, Syria

RECRUITING

Related 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.

  PMID: 8181550 BACKGROUND

• 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.

  PMID: 3422118 BACKGROUND

• 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.

  PMID: 16679196 BACKGROUND

• 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.

  PMID: 23201327 BACKGROUND

• 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.

  PMID: 8978727 BACKGROUND

• 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.

  PMID: 10629520 BACKGROUND

• 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.

  PMID: 2220695 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Rabab Alsabbagh,, DDS MSc PhD

  Professor of Orthodontics, University of Hama Dental School, Hama, Syria.

  STUDY DIRECTOR

• ANAS FAKHOURI

  Student in Orthodontics, University of Hama Dental School, Hama.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fadi Jnaid

CONTACT

988499015; Drfadijnaid@gmail.com

Fadi Jnaid

CONTACT

fadijnaid@hama-univ.edu.sy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: March 15, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)