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

NCT05950581 — Not applicable, Recruiting, 32 participants, Hama University

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

RegistryNCT05950581
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment32 (Estimated)
SponsorHama University (Other)
ConditionsMalocclusion, Angle Class II
InterventionsModified Twin-Block Appliance with Clear Plates., Traditional Twin-Block appliance (Device)
Datesstart 2027-03-15 (estimated), primary completion 2027-07-15 (estimated), completion 2027-09-15 (estimated), first posted 2023-07-18, last updated 2026-09-16
Locations1 site in Syria

Related Papers Related Patents Related Grants Related Experts
All trials for Malocclusion, Angle Class II All trials of Modified Twin-Block Appliance with Clear Plates. All trials of Traditional Twin-Block appliance

-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.

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+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

+Arms and interventions

ArmTypeInterventionsDescription
: Modified Twin-Block Appliance with Clear Plates.ExperimentalDevice: 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.
Traditional Twin-Block applianceExperimentalDevice: Traditional Twin-Block applianceTraditional 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
  • 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
  • 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

+Outcome measures

Primary outcomes

  • Change in the SNA angle[ [: 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)]: 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 [ [: 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)]: 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 [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)]: 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 [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)]: 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 [: 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)]: The vertical distance from the edge of the lower incisor to the mandibular plane.

+Eligibility

Sex: All, ages: 10 Years to 13 Years

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.

+Locations (1)

FacilityCityCountryStatus
Hama UniversityHamaSyriaRecruiting

+Publications

  • 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
  • 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
  • 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
  • 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
  • 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. PMID 19852643
  • 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
  • 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

+Investigators

  • Rabab Alsabbagh,, DDS MSc PhD, Study director, Professor of Orthodontics, University of Hama Dental School, Hama, Syria.
  • ANAS FAKHOURI, Principal investigator, Student in Orthodontics, University of Hama Dental School, Hama.