Removable Devices in Overjet Reduction

Not Applicable

Completed

• Conditions: Skeletal Class II Malocclusion; Dental Overjet

• Registration Number: NCT06955637
• Lead Sponsor: University of L'Aquila

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Primary Completion: 2024-02-27
• Study Completion: 2024-02-28
• Status Verified: 2024-03
• Study First Submitted: 2025-04-16
• Study First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Study First Posted: 2025-05-02
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in the horizontal distance between the upper and lower incisors	12 months	To evaluate the possible reduction of the horizontal distance between the incisors of the two dental arches at two specific times

Trial Locations

Locations (1)

Dipartimento MESVA; 🇮🇹 L'Aquila, Italia, Italy