Comparison Between Removable Devices in Overjet Reduction: a Randomised Open Label Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of L'Aquila
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Changes in the horizontal distance between the upper and lower incisors
Study Overview
Brief Summary
The goal of this clinical trial si to compare two removable devices used to treat the mandibular retrusion in growing patients.
The main questions it aims to answer are:
- the efficacy of the two devices in the reduction of the overjet
- the neuromuscolar effects developed on the stomatognatic system Participants will be instructed in the use and maintenance of the devices and will be checked every 15-30 days for one year.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 9 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •skeletal class II relationship,
- •complete eruption of upper first premolars
- •presence of unilateral or bilateral cross bite (falling within grade 3 IOTN index).
Exclusion Criteria
- •IOTN (INDEX OF ORTHODONTIC TREATMENT NEED) index > 4;
- •presence of epilepsy,
- •systemic disease,
- •TMD, or periodontal disease;
- •lack of written informed consent from a parent or legal guardian.
Arms & Interventions
Elastodontic removable device
Patients in this group will be treat with an elastodontic device adapted to the patient according to the shape of the dental arches. This device is similar to a mouthguard and embraces both dental arches. This appliance is worn overnight and the patient will be checked every month. The degree of will be taken at T0( before the start of the therapy), at T1 (after six months)and at T2 (after one month). All the dental recors will be taken by the same operator with an intraoral scanner 3D.
Intervention: dental movement (Device)
Clear Aligners
Patients in this group will be treat with clear aligners of the dental arches. This removable device Is transparent and covers all tooth surfaces perfectly. This appliance is 22 hours at day and the patient will be checked every month. The degree of will be taken at T0( before the start of the therapy), at T1 (after six months)and at T2 (after one month). All the dental records will be taken by the same operator with an intraoral scanner 3D.
Intervention: dental movement (Device)
Outcomes
Primary Outcomes
Changes in the horizontal distance between the upper and lower incisors
Time Frame: 12 months
To evaluate the possible reduction of the horizontal distance between the incisors of the two dental arches at two specific times
Secondary Outcomes
No secondary outcomes reported
Investigators
Eleonora Ortu
Researcher
University of L'Aquila