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Completed

NCT Number: NCT04337086

Effect of T4K Versus Twin Block in Developing Class II Division I Malocculsion

The aim of this study was to evaluate and compare the effect of myofunctional trainer T4K versus twin block functional appliance on the dentoalveolar changes in children with class II division I malocclusion

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Key information

Conditions

Orthodontic Appliances

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

About this study

This study was a parallel arm randomized comparative clinical trial including 20 healthy children age ranged from 9-12 years showing Angle's class II division I malocclusion due to mandibular retrusion. Preoperative photographs, radiographs and study casts were taken, children were randomly assigned into two groups according to the appliance used; Group 1: T4k, and Group II: twin block. Follow up was done every 4 weeks for 9 months. Postoperative cephalometric X ray, study casts and photographs were retaken for measurements and comparison.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Angle's class II division I malocclusion due to mandibular retrusion depending on clinical judgement and confirmed with the lateral cephalometric X-ray.
  • Parental written consent was secured.

Exclusion criteria

  • Patients with mandibular shifts.
  • Patients with severe crowding.
  • Patients with anterior open bite.
  • Patients with posterior crossbite.
  • Patients with any peri-oral habits.
  • Patients who had received any previous orthodontic or orthopaedic treatments.

Treatment and study plan

T4k Appliance

Device

The pre-fabricated, hard, polyurethane, pink T4K™ (Myo functional research Co., Australia) was used in the study. It consisted of: facial bows, lingual bows / tongue guard, lingual tag / tongue tag, dental channels with a pre-determined bite position and a lip bumper. In the first week, the patients were instructed to gradually increase the wearing time of the appliance during the daytime. By the second week, the patients were instructed to wear the appliance achieving at least 8 hours during sleeping. The Trainer usually needs no adjustments. The patients were asked to place it themselves inside their mouths. The distal ends of the appliance were trimmed 2-3 mm with an acrylic bur on a straight hand piece if they were too long or the patient could not keep his lips together. By the end of the first 4 weeks, the patients were wearing the appliances minimum of 1 hour during the day plus the overnight wear following the manufacturer's instructions.

Twin block appliance

Device

The twin block was used, and instructions were given to wear the appliance nearly full-time. Selective sequential inter-occlusal trimming was done monthly after the 2nd month in the occlusal surface of the maxillary bite blocks to clear over the mandibular molars allowing their eruption in a more favourable mesial direction and to increase the vertical dimension. Trimming was done in the fitting surface over the maxillary and mandibular premolars whenever needed to allow their full eruption and to level the occlusal plane

Primary outcomes

  1. Dento-alveolar changes

    Time frame: baseline

    This was assessed using lateral cephalometric xrays. Inclination of of maxillary incisor was assessed by measuring the angle to Frankfurt horizontal plane

  2. Dento-alveolar changes

    Time frame: 9 months

    This was assessed using lateral cephalometric xrays. Inclination of of maxillary incisor was assessed by measuring the angle to Frankfurt horizontal plane

  3. Overjet

    Time frame: baseline

    the extent of horizontal (anterior-posterior) overlap of the maxillary central incisors over the mandibular central incisors was measured on study casts.

  4. Overjet

    Time frame: 9 months

    the extent of horizontal (anterior-posterior) overlap of the maxillary central incisors over the mandibular central incisors was measured on study casts.

  5. Overbite

    Time frame: baseline

    the extent of vertical (superior-inferior) overlap of the maxillary central incisors over the mandibular central incisors, measured relative to the incisal ridges. This was assessed on study casts

  6. Overbite

    Time frame: 9 months

    the extent of vertical (superior-inferior) overlap of the maxillary central incisors over the mandibular central incisors, measured relative to the incisal ridges. This was assessed on study casts

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Collaborators

  • Alexandria University

Registry information

Official study title

The Effect of T4K Versus Twin Block in Developing Class II Division I Malocculsion (Randomized Controlled Clinical Trial)

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 7, 2020
Registry last updated
Apr 8, 2020

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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