Removable Devices in Overjet Reduction

NCT ID: NCT06955637

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-02-28

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.

Conditions

Skeletal Class II Malocclusion; Dental Overjet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

dental movement

Intervention Type: DEVICE

Possibility to reduce the protrusion of upper incisors

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.

Group Type: EXPERIMENTAL

dental movement

Intervention Type: DEVICE

Possibility to reduce the protrusion of upper incisors

Interventions

dental movement

Possibility to reduce the protrusion of upper incisors

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of L'Aquila

OTHER

Sponsor Role: lead

Responsible Party

Eleonora Ortu

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dipartimento MESVA

L’Aquila, Italia, Italy

Countries

Italy

Other Identifiers

IRB L'Aquila 02/2021

Identifier Type: -

Identifier Source: org_study_id