Removable Devices in Overjet Reduction (RemoDevOJ)

University of L'Aquila

Status: Completed

Conditions: Dental Overjet; Skeletal Class II Malocclusion

Treatments: Device: dental movement

Study type: Interventional

Funder types: Other

Identifiers

NCT06955637

IRB L'Aquila 02/2021

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 9 to 15 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Elastodontic removable device

Experimental group

Description:

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.

Treatment:

Device: dental movement

Clear Aligners

Experimental group

Description:

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.

Treatment:

Device: dental movement