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

NCT ID: NCT04337086

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-23
• Study Completion Date: 2010-12-18

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

Detailed Description

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.

Conditions

Orthodontic Appliances

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

T4k

Group Type: EXPERIMENTAL

T4k Appliance

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Twin block appliance

Intervention Type: 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

Interventions

T4k Appliance

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.

Intervention Type: DEVICE

Twin block appliance

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: collaborator

Nourhan M.Aly

OTHER

Sponsor Role: lead

Responsible Party

Nourhan M.Aly

Dental Public Health clinical instructor and statistician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yasmine El Hamouly, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Pharos University in Alexandria.

Hanan A Ismaiel, PhD

Role: STUDY_CHAIR

Faculty of Dentistry, Alexandria University, Egypt

Azza A ElHousseiny, PhD

Role: STUDY_CHAIR

Faculty of Dentistry, Alexandria University, Egypt

Laila M El Habashy, PhD

Role: STUDY_CHAIR

Faculty of Dentistry, Alexandria University, Egypt

Locations

Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

T4k versus Twin block

Identifier Type: -

Identifier Source: org_study_id