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OpenTrials
Completed

NCT Number: NCT06955637

Removable Devices in Overjet Reduction

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.

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Key information

Conditions

Skeletal Class II Malocclusion Dental Overjet Malocclusion Malocclusion, Angle Class II Overbite Stomatognathic Diseases Tooth Diseases

Age range

9 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dipartimento MESVA

L’Aquila, Italia, 67100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dental movement

Device

Possibility to reduce the protrusion of upper incisors

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of L'Aquila

Other

Registry information

Official study title

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

Acronym: RemoDevOJ

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 2, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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