Clinical trial NCT05950581: 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
Overall status: RECRUITING
Phase: NA
Conditions: Malocclusion, Angle Class II
Lead sponsor: Hama University
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 32
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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

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.

Primary outcomes:
measure: Change in the SNA angle[
timeFrame: : 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)
measure: change in the SNB angle [
timeFrame: : 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)
measure: change in the mandibular length
timeFrame: 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)
measure: change in overjet
timeFrame: 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)
measure: change in the vertical position of incisors
timeFrame: : 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Hama
country: Syrian Arab Republic
facility: Hama University
Study officials:
affiliation: Professor of Orthodontics, University of Hama Dental School, Hama, Syria.
name: Rabab Alsabbagh,, DDS MSc PhD
role: STUDY_DIRECTOR
affiliation: Student in Orthodontics, University of Hama Dental School, Hama.
name: ANAS FAKHOURI
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.