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

Skeletal Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824574
• Other study ID #: AinShamsUOrthodontics
• Status: Completed
• Phase: N/A
• Start date: September 20, 2016
• Est. completion date: March 4, 2018

Study information

• Verified date: January 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A Clear mandibular advancement appliance is constructed comprised of a clear dental splint of 1.5 mm thickness adapted on the patient's teeth. This is followed by the construction of acrylic bite ramps bonded over the splints. The bite ramps are constructed as such when the patient bites into occlusion, he/she has to advance the mandible to bring the two parts of the appliance together. Lateral cephalometric radiographs were obtained pre and post-treatment to evaluate the effects on the patient's maxilla, mandible and dentition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 4, 2018
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Gender: Female subjects.

2. Chronological age: All recruited subjects were between the ages of 8-12 years.

3. 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.

4. 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.

5. 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.

6. No previous history of orthodontic treatment.

7. Absence of systemic diseases affecting growth or craniofacial development. -

Exclusion Criteria:

Related Conditions & MeSH terms

• Malocclusion
• Skeletal Malocclusion

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

References & Publications (17)

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. — View Citation

Clark WJ. The twin block technique. A functional orthopedic appliance system. Am J Orthod Dentofacial Orthop. 1988 Jan;93(1):1-18. — View 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Teuscher U. A growth-related concept for skeletal class II treatment. Am J Orthod. 1978 Sep;74(3):258-75. — View Citation

Toth LR, McNamara JA Jr. Treatment effects produced by the twin-block appliance and the FR-2 appliance of Fränkel compared with an untreated Class II sample. Am J Orthod Dentofacial Orthop. 1999 Dec;116(6):597-609. — View 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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective Mandibular Length	Condylion-Gnathion	12 months
Primary	Mandible to cranial base	Sella-Nasion-B point	12 months
Primary	Effective maxillary length	Condylion-A point	12 months
Primary	Maxilla to cranial base	Sella-Nasion-A point	12 months
Secondary	Lower incisor inclination	Lower incisor to mandibular plane	12 months
Secondary	Lower incisor AP position	Lower incisor Anteroposterior position	12 months
Secondary	Upper incisor inclination	Upper incisor to palatal plane	12 months
Secondary	Upper incisor AP position	Upper incisor Anteroposterior position	12 months
Secondary	Profile convexity	N'Sn/Sn-Pog'	12 months
Secondary	Lip protrusion	Ls-E plane	12 months
Secondary	Chin position	Soft tissue Pogonion position	12 months