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

April 6, 2020 updated by: Nourhan M.Aly

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21512
        • Faculty of Dentistry, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: T4k
Device: 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.
Active Comparator: Twin block
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline
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
9 months
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.
baseline
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.
9 months
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
baseline
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
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nourhan M.Aly

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alexandria University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Laila M El Habashy, PhD, Faculty of Dentistry, Alexandria University, Egypt
  • Principal Investigator: Yasmine El Hamouly, PhD, Faculty of Dentistry, Pharos University in Alexandria.
  • Study Chair: Hanan A Ismaiel, PhD, Faculty of Dentistry, Alexandria University, Egypt
  • Study Chair: Azza A ElHousseiny, PhD, Faculty of Dentistry, Alexandria University, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • T4k versus Twin block

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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