The Effect of T4K Versus Twin Block in Developing Class II Division I Malocculsion (Randomized Controlled Clinical Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Overbite
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
This study was a double-blind study, as the participant and the outcome assessors were blinded to the type of treatment.
Eligibility Criteria
- Ages
- 9 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
T4k
Intervention: T4k Appliance (Device)
Twin block
Intervention: Twin block appliance (Device)
Outcomes
Primary Outcomes
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
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
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.
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
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.
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Nourhan M.Aly
Dental Public Health clinical instructor and statistician
University of Alexandria