Cephalometric Evaluation of a Clear Mandibular Advancement Appliance Based on the Twin-block Design

NCT03824574 | Completed DMC

• 1 other identifier: AinShamsUOrthodontics
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the cephalometric effects of a clear mandibular advancement appliance for the treatment of skeletal class II growing patients suffering from mandibular deficiency.

Conditions

Skeletal Malocclusion

Keywords

Functional appliance; skeletal class II; mandibular deficiency; twin-block; Growing patients; Clear appliance; Aligner

Outcome Measures

Primary Outcomes (4)

• Effective Mandibular Length

  Condylion-Gnathion

  12 months

• Mandible to cranial base

  Sella-Nasion-B point

  12 months

• Effective maxillary length

  Condylion-A point

  12 months

• Maxilla to cranial base

  Sella-Nasion-A point

  12 months

Secondary Outcomes (7)

• Lower incisor inclination

  12 months

• Lower incisor AP position

  12 months

• Upper incisor inclination

  12 months

• Upper incisor AP position

  12 months

• Profile convexity

  12 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

Subjects receiving the clear mandibular advancement appliance

Device: Clear Mandibular Advancement Appliance

Interventions

Clear Mandibular Advancement Appliance DEVICE

Clear Mandibular Advancement Appliance for treatment of skeletal class II patients with retrognathic mandible

Treatment arm

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gender: Female subjects.
• Chronological age: All recruited subjects were between the ages of 8-12 years.
• Anteroposterior skeletal relationship: Subjects with skeletal Class II malocclusion with normal maxilla and retrognathic mandible were selected. This was confirmed using lateral cephalometric radiographic analysis with the following parameters: decreased effective mandibular length (Co-Gn) according to McNamara composite , SNB\<78, SNA=82+2.
• Dental characteristics:
• Angle Class II molar relationship ranging from edge to edge to full unit Class II.
• Overjet ranging between 5-10 mm.
• Absence of posterior crossbite and/or tendency for posterior crossbite.
• Skeletal maturation stage: The growth stage for all subjects was selected to be before or at the prepubertal growth spurt. This was confirmed by cervical vertebral maturation analysis from the lateral cephalometric radiograph. The cervical vertebrae maturation stage required was Cervical Vertebrae Maturation stage 2-3 according to the cervical vertebrae maturation index by Baccetti et al. allowing sufficient time before the end of the growth spurt.
• No previous history of orthodontic treatment.
• Absence of systemic diseases affecting growth or craniofacial development. -

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (17)

• Jena AK, Duggal R, Parkash H. Skeletal and dentoalveolar effects of Twin-block and bionator appliances in the treatment of Class II malocclusion: a comparative study. Am J Orthod Dentofacial Orthop. 2006 Nov;130(5):594-602. doi: 10.1016/j.ajodo.2005.02.025.

  PMID: 17110256 BACKGROUND

• Teuscher U. A growth-related concept for skeletal class II treatment. Am J Orthod. 1978 Sep;74(3):258-75. doi: 10.1016/0002-9416(78)90202-6.

  PMID: 281130 BACKGROUND

• Lv Y, Yan B, Wang L. Two-phase treatment of skeletal class II malocclusion with the combination of the twin-block appliance and high-pull headgear. Am J Orthod Dentofacial Orthop. 2012 Aug;142(2):246-55. doi: 10.1016/j.ajodo.2010.12.024.

  PMID: 22858335 BACKGROUND

• O'Brien K, Macfarlane T, Wright J, Conboy F, Appelbe P, Birnie D, Chadwick S, Connolly I, Hammond M, Harradine N, Lewis D, Littlewood S, McDade C, Mitchell L, Murray A, O'Neill J, Sandler J, Read M, Robinson S, Shaw I, Turbill E. Early treatment for Class II malocclusion and perceived improvements in facial profile. Am J Orthod Dentofacial Orthop. 2009 May;135(5):580-5. doi: 10.1016/j.ajodo.2008.02.020.

  PMID: 19409340 BACKGROUND

• Tulloch JF, Phillips C, Koch G, Proffit WR. The effect of early intervention on skeletal pattern in Class II malocclusion: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 1997 Apr;111(4):391-400. doi: 10.1016/s0889-5406(97)80021-2.

  PMID: 9109584 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

• Baccetti T, Franchi L, Toth LR, McNamara JA Jr. Treatment timing for Twin-block therapy. Am J Orthod Dentofacial Orthop. 2000 Aug;118(2):159-70. doi: 10.1067/mod.2000.105571.

  PMID: 10935956 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

• Toth LR, McNamara JA Jr. Treatment effects produced by the twin-block appliance and the FR-2 appliance of Frankel compared with an untreated Class II sample. Am J Orthod Dentofacial Orthop. 1999 Dec;116(6):597-609. doi: 10.1016/s0889-5406(99)70193-9.

  PMID: 10587592 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

• Mills CM, McCulloch KJ. Posttreatment changes after successful correction of Class II malocclusions with the twin block appliance. Am J Orthod Dentofacial Orthop. 2000 Jul;118(1):24-33. doi: 10.1067/mod.2000.104902.

  PMID: 10893470 BACKGROUND

• Singh GD, Hodge MR. Bimaxillary morphometry of patients with class II division 1 malocclusion treated with twin block appliances. Angle Orthod. 2002 Oct;72(5):402-9. doi: 10.1043/0003-3219(2002)0722.0.CO;2.

  PMID: 12401048 BACKGROUND

• Schaefer AT, McNamara JA Jr, Franchi L, Baccetti T. A cephalometric comparison of treatment with the Twin-block and stainless steel crown Herbst appliances followed by fixed appliance therapy. Am J Orthod Dentofacial Orthop. 2004 Jul;126(1):7-15. doi: 10.1016/j.ajodo.2003.06.017.

  PMID: 15224053 BACKGROUND

• O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I. Effectiveness of treatment for Class II malocclusion with the Herbst or twin-block appliances: a randomized, controlled trial. Am J Orthod Dentofacial Orthop. 2003 Aug;124(2):128-37. doi: 10.1016/s0889-5406(03)00345-7.

  PMID: 12923506 BACKGROUND

• Flores-Mir C, Major PW. Cephalometric facial soft tissue changes with the twin block appliance in Class II division 1 malocclusion patients. A systematic review. Angle Orthod. 2006 Sep;76(5):876-81. doi: 10.1043/0003-3219(2006)076[0876:CFSTCW]2.0.CO;2.

  PMID: 17029526 BACKGROUND

• Khoja A, Fida M, Shaikh A. Cephalometric evaluation of the effects of the Twin Block appliance in subjects with Class II, Division 1 malocclusion amongst different cervical vertebral maturation stages. Dental Press J Orthod. 2016 Jun;21(3):73-84. doi: 10.1590/2177-6709.21.3.073-084.oar.

  PMID: 27409656 BACKGROUND

• Mills CM, McCulloch KJ. Treatment effects of the twin block appliance: a cephalometric study. Am J Orthod Dentofacial Orthop. 1998 Jul;114(1):15-24. doi: 10.1016/s0889-5406(98)70232-x.

  PMID: 9674675 BACKGROUND

MeSH Terms

Conditions

Micrognathism

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Orthodontics

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: September 20, 2016
• Primary Completion: December 15, 2017
• Study Completion: March 4, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01