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

NCT ID: NCT05950581

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-15

Study Completion Date

2026-09-15

Brief Summary

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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

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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

Conditions

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Malocclusion, Angle Class II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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: 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.

Group Type EXPERIMENTAL

Modified Twin-Block Appliance with Clear Plates.

Intervention Type 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

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

Group Type EXPERIMENTAL

Traditional Twin-Block appliance

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hama University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rabab Alsabbagh,, DDS MSc PhD

Role: STUDY_DIRECTOR

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

ANAS FAKHOURI

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Hama University

Hama, , Syria

Site Status RECRUITING

Countries

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Syria

Central Contacts

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Fadi Jnaid

Role: CONTACT

988499015

Fadi Jnaid

Role: CONTACT

Facility Contacts

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Fadi Jnaid

Role: primary

988499015

References

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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.

Reference Type BACKGROUND
PMID: 8181550 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3422118 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16679196 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23201327 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8978727 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10629520 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2220695 (View on PubMed)

Other Identifiers

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Hama University -Orthdontic.

Identifier Type: -

Identifier Source: org_study_id

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