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

NCT04337086 | Completed

• 1 other identifier: T4k versus Twin block
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Orthodontic Appliances

Outcome Measures

Primary Outcomes (6)

• Dento-alveolar changes

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

  baseline

• Dento-alveolar changes

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

  9 months

• Overjet

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

  baseline

• Overjet

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

  9 months

• Overbite

  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

  baseline

• Overbite

  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

  9 months

Study Arms (2)

T4k

EXPERIMENTAL

Device: T4k Appliance

Twin block

ACTIVE COMPARATOR

Device: Twin block appliance

Interventions

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.

T4k

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

Twin block

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Study Officials

• Yasmine El Hamouly, PhD

  Faculty of Dentistry, Pharos University in Alexandria.

  PRINCIPAL INVESTIGATOR

• Hanan A Ismaiel, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Azza A ElHousseiny, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Laila M El Habashy, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study was a double-blind study, as the participant and the outcome assessors were blinded to the type of treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dental Public Health clinical instructor and statistician

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 7, 2020
• Study Start: January 23, 2008
• Primary Completion: November 30, 2010
• Study Completion: December 18, 2010
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

EG (1)