Skeletal Class II MalocclusionRemoDevOJNCT06955637
Removable Devices in Overjet Reduction
A study testing dental movement in people with Skeletal Class II Malocclusion and Dental Overjet, run by University of L'Aquila at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Skeletal Class II Malocclusion, Dental Overjet
- What is being tested?
- dental movement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2023to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- skeletal class II relationship,
- complete eruption of upper first premolars
- presence of unilateral or bilateral cross bite (falling within grade 3 IOTN index).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Skeletal Class II Malocclusion, Dental Overjet
- Being tested
- dental movement
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental movementDevice
Possibility to reduce the protrusion of upper incisors
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: dental movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start1 Dec 2023
- Primary completion27 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Class II MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleonora Ortu, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955637
- Sponsor's protocol ID
- IRB L'Aquila 02/2021
- Acronym
- RemoDevOJ
- Status last verified
- Mar 2024
- First submitted
- 16 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Removable Devices in Overjet Reduction: a Randomised Open Label Clinical Trial
- ClinicalTrials.gov ID
- NCT06955637
- Acronym / sponsor ID
- RemoDevOJ / IRB L'Aquila 02/2021
- Conditions
- Skeletal Class II Malocclusion, Dental Overjet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elastodontic removable device | Experimental | Device: dental movementPatients 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. |
| Clear Aligners | Experimental | Device: dental movementPatients 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. |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- skeletal class II relationship,
- complete eruption of upper first premolars
- presence of unilateral or bilateral cross bite (falling within grade 3 IOTN index).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dental movementPossibility to reduce the protrusion of upper incisors | Device | Clear Aligners, Elastodontic removable device |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
Related trials for Skeletal Class II Malocclusion
Recruiting
Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
Recruiting
Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates
Malocclusion, Angle Class II
Not yet recruiting
Clinical and Radiographic Evaluation of Low Sagittal Medial Ramus Osteotomy for Treatment of Skeletal Class II and Class III Malocclusion
Skeletal Class II Malocclusion, Skeletal Class III Malocclusion
Active, not recruiting
Modified Versus Clear Twin Block for Skeletal Class II Malocclusion
Skeletal Class II Malocclusion
Recruiting
Twin-Block and LIPUS for TMJ Outcomes in Skeletal Class II Patients
CLASS II DIVISION 1 MALOCCLUSION
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental movement in people with Skeletal Class II Malocclusion and Dental Overjet, run by University of L'Aquila at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the horizontal distance between the upper and lower incisors (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.