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Completed

NCT Number: NCT03824574

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Clear Mandibular Advancement Appliance

Device

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

Primary outcomes

  1. Effective Mandibular Length

    Time frame: 12 months

    Condylion-Gnathion

  2. Mandible to cranial base

    Time frame: 12 months

    Sella-Nasion-B point

  3. Effective maxillary length

    Time frame: 12 months

    Condylion-A point

  4. Maxilla to cranial base

    Time frame: 12 months

    Sella-Nasion-A point

Secondary outcomes

  1. Lower incisor inclination

    Time frame: 12 months

    Lower incisor to mandibular plane

  2. Lower incisor AP position

    Time frame: 12 months

    Lower incisor Anteroposterior position

  3. Upper incisor inclination

    Time frame: 12 months

    Upper incisor to palatal plane

  4. Upper incisor AP position

    Time frame: 12 months

    Upper incisor Anteroposterior position

  5. Profile convexity

    Time frame: 12 months

    N'Sn/Sn-Pog'

  6. Lip protrusion

    Time frame: 12 months

    Ls-E plane

  7. Chin position

    Time frame: 12 months

    Soft tissue Pogonion position

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jan 31, 2019
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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