Removable Devices in Overjet Reduction (RemoDevOJ)

April 24, 2025 updated by: Eleonora Ortu, University of L'Aquila

Comparison Between Removable Devices in Overjet Reduction: a Randomised Open Label Clinical Trial

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italia
      • L'Aquila, Italia, Italy, 67100
        • Dipartimento MESVA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: dental movement
Possibility to reduce the protrusion of upper incisors
Experimental: 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.
Device: dental movement
Possibility to reduce the protrusion of upper incisors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of L'Aquila

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

February 27, 2024

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

April 16, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 2, 2025

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB L'Aquila 02/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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