Removable Devices in Overjet Reduction

NCT06955637 | Completed

• 1 other identifier: IRB L'Aquila 02/2021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes in the horizontal distance between the upper and lower incisors

  To evaluate the possible reduction of the horizontal distance between the incisors of the two dental arches at two specific times

  12 months

Study Arms (2)

Elastodontic removable device

EXPERIMENTAL

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.

Device: dental movement

Clear Aligners

EXPERIMENTAL

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.

Device: dental movement

Interventions

dental movement DEVICE

Possibility to reduce the protrusion of upper incisors

Clear Aligners; Elastodontic removable device

Eligibility Criteria

• Age: 9 Years - 15 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• skeletal class II relationship,
• complete eruption of upper first premolars
• presence of unilateral or bilateral cross bite (falling within grade 3 IOTN index).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of L'Aquila: lead

Study Sites (1)

Dipartimento MESVA

L’Aquila, Italia, 67100, Italy

Location

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class II; Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 2, 2025
• Study Start: December 1, 2023
• Primary Completion: February 27, 2024
• Study Completion: February 28, 2024
• Last Updated: May 2, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)