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

Primary Purpose

Skeletal Malocclusion

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Clear Mandibular Advancement Appliance

About this trial

This is an interventional treatment trial for Skeletal Malocclusion focused on measuring Functional appliance, skeletal class II, mandibular deficiency, twin-block, Growing patients, Clear appliance, Aligner

Eligibility Criteria

8 Years - 12 Years (Child)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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. -

Exclusion Criteria:

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment arm

Arm Description

Subjects receiving the clear mandibular advancement appliance

Outcomes

Primary Outcome Measures

Effective Mandibular Length

Condylion-Gnathion

Mandible to cranial base

Sella-Nasion-B point

Effective maxillary length

Condylion-A point

Maxilla to cranial base

Sella-Nasion-A point

Secondary Outcome Measures

Lower incisor inclination

Lower incisor to mandibular plane

Lower incisor AP position

Lower incisor Anteroposterior position

Upper incisor inclination

Upper incisor to palatal plane

Upper incisor AP position

Upper incisor Anteroposterior position

Profile convexity

N'Sn/Sn-Pog'

Lip protrusion

Ls-E plane

Chin position

Soft tissue Pogonion position

Full Information

NCT ID

NCT03824574

First Posted

January 29, 2019

Last Updated

January 29, 2019

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT03824574

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

September 20, 2016 (Actual)

Primary Completion Date

December 15, 2017 (Actual)

Study Completion Date

March 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skeletal Malocclusion

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment arm

Arm Type

Experimental

Arm Description

Subjects receiving the clear mandibular advancement appliance

Intervention Type

Device

Intervention Name(s)

Clear Mandibular Advancement Appliance

Intervention Description

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

Primary Outcome Measure Information:

Title

Effective Mandibular Length

Description

Condylion-Gnathion

Time Frame

12 months

Title

Mandible to cranial base

Description

Sella-Nasion-B point

Time Frame

12 months

Title

Effective maxillary length

Description

Condylion-A point

Time Frame

12 months

Title

Maxilla to cranial base

Description

Sella-Nasion-A point

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Lower incisor inclination

Description

Lower incisor to mandibular plane

Time Frame

12 months

Title

Lower incisor AP position

Description

Lower incisor Anteroposterior position

Time Frame

12 months

Title

Upper incisor inclination

Description

Upper incisor to palatal plane

Time Frame

12 months

Title

Upper incisor AP position

Description

Upper incisor Anteroposterior position

Time Frame

12 months

Title

Profile convexity

Description

N'Sn/Sn-Pog'

Time Frame

12 months

Title

Lip protrusion

Description

Ls-E plane

Time Frame

12 months

Title

Chin position

Description

Soft tissue Pogonion position

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. - Exclusion Criteria: -

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

17110256

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. doi: 10.1016/j.ajodo.2005.02.025.

Results Reference

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Citation

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Citation

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Citation

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PubMed Identifier

9109584

Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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

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