OverjetNCT06653075
Mandibular Advancement Planning Based on Clinical Overjet
A study testing mandibular advancement with acrylic splint Herbst Appliance in people with Overjet and Class II Division 1 Malocclusion, run by IRCCS Ospedale San Raffaele at 1 site in Italy.
Trial summary
This Prospective study aims to simulate the maximum mandibular advancement in class II patients treated by Herbst MTH Appliance on the base on clinical overjet. Initial intraoral scans will be uploaded in Suresmile software, the upper incisors will be virtually aligned and the mandible will be advancement until an… Read more about this study
- Who is it for?
- Ages 6 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overjet, Class II Division 1 Malocclusion
- What is being tested?
- mandibular advancement with acrylic splint Herbst Appliance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 30 Oct 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ANB>=4°
- Overjet >=4 mm
- Class II malocclusion ( bilateral class II molar relation, at least half a cusp)
Who cannot join
- tooth agenesis
- poor oral hygiene
- previous orthodontic treatments
- systemic disease or bone pathology
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Vita-Salute San Raffaele University
Milan
Giorgio Gastaldi, DM,DDS, gastaldi.giorgio@hsr.it
About this study
Official title: Role of Clinical Overjet for Mandibular Advancement: a Prospective Study
This Prospective study aims to simulate the maximum mandibular advancement in class II patients treated by Herbst MTH Appliance on the base on clinical overjet.
Initial intraoral scans will be uploaded in Suresmile software, the upper incisors will be virtually aligned and the mandible will be advancement until an anterior occlusal contact will be reached. This virtual advancement will be compared to the real advancement obtained at the end of the Herbst phase.
This protocol will be applied to two groups: one with traditional dental occlusion, the second one with Skeletal anchorage reinforcement and elastic chains
- Conditions
- Overjet, Class II Division 1 Malocclusion
- Being tested
- mandibular advancement with acrylic splint Herbst Appliance
- Medical subject headings
- Overbite, Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mandibular advancement with acrylic splint Herbst ApplianceProcedure or surgery
Mandibular advancement with acrylic splint Herbst Appliance
| Study group | Role | What they receive |
|---|---|---|
| traditional anchorage | Active comparator | Skeletal class II patients treated by Herbst Appliance with traditional dental anchorage Receives: Procedure: mandibular advancement with acrylic splint Herbst Appliance |
| skeletal anchorage | Experimental | Skeletal class II patients treated by Herbst Appliance with skeletal anchorage Receives: Procedure: mandibular advancement with acrylic splint Herbst Appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Planned mandibular advancement (mm)
The "planned mandibular advancement" will be evaluated on the STL of the arches by simulating a sagittal mandibular advancement , until an anterior occlusal contact will be reached
Measured: 1 year
Secondary outcomes (1)
Obtained mandibular advancement (mm)
The obtained mandibular advancement will be evaluated comparing the Sagittal position of the Pogonion (according to cephalometric pancherz's analysis) on the lateral ceph before and after the treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start30 Oct 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OverjetStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giorgio Gastaldi, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653075
- Sponsor's protocol ID
- OJ2024
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manni A, Lupini D, Cozzani M. Les elastiques intermaxillaires a ancrage osseux dans une malocclusion de Classe II asymetrique : une etude de cas. Int Orthod. 2017 Jun;15(2):263-277. doi: 10.1016/j.ortho.2017.03.012. Epub 2017 Apr 25. No abstract available. French.
PubMed 28389184Manni A, Boggio A, Gastaldi G, Cozzani M. Is significant mandibular advancement possible after the peak of puberty? Dento-osseous palatal expansion and the STM4 technique (Skeletal Therapy Manni Telescopic Herbst 4 miniscrews): A case report. Int Orthod. 2024 Jun;22(2):100868. doi: 10.1016/j.ortho.2024.100868. Epub 2024 Mar 11.
PubMed 38471383Manni A, Boggio A, Caldara G, Gastaldi G, Cozzani M. Herbst appliance with four-miniscrew anchorage for mandibular advancement after the pubertal peak. J Clin Orthod. 2024 Aug;58(8):505-513. No abstract available.
PubMed 39307830Manni A, Pasini M, Mauro C. Comparison between Herbst appliances with or without miniscrew anchorage. Dent Res J (Isfahan). 2012 Dec;9(Suppl 2):S216-21. doi: 10.4103/1735-3327.109762.
PubMed 23814587Manni A, Mutinelli S, Cerruto C, Cozzani M. Influence of incisor position control on the mandibular response in growing patients with skeletal Class II malocclusion. Am J Orthod Dentofacial Orthop. 2021 May;159(5):594-603. doi: 10.1016/j.ajodo.2020.02.014. Epub 2021 Feb 7.
PubMed 33563504Manni A, Migliorati M, Calzolari C, Silvestrini-Biavati A. Herbst appliance anchored to miniscrews in the upper and lower arches vs standard Herbst: A pilot study. Am J Orthod Dentofacial Orthop. 2019 Nov;156(5):617-625. doi: 10.1016/j.ajodo.2018.11.015.
PubMed 31677670
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Clinical Overjet for Mandibular Advancement: a Prospective Study
- ClinicalTrials.gov ID
- NCT06653075
- Acronym / sponsor ID
- OJ2024
- Conditions
- Overjet, Class II Division 1 Malocclusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Oct 2024 (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.
This Prospective study aims to simulate the maximum mandibular advancement in class II patients treated by Herbst MTH Appliance on the base on clinical overjet.
Initial intraoral scans will be uploaded in Suresmile software, the upper incisors will be virtually aligned and the mandible will be advancement until an anterior occlusal contact will be reached. This virtual advancement will be compared to the real advancement obtained at the end of the Herbst phase.
This protocol will be applied to two groups: one with traditional dental occlusion, the second one with Skeletal anchorage reinforcement and elastic chains
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional anchorage | Active comparator | Procedure: mandibular advancement with acrylic splint Herbst ApplianceSkeletal class II patients treated by Herbst Appliance with traditional dental anchorage |
| skeletal anchorage | Experimental | Procedure: mandibular advancement with acrylic splint Herbst ApplianceSkeletal class II patients treated by Herbst Appliance with skeletal anchorage |
Who may qualify
- Ages
- 6 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- ANB>=4°
- Overjet >=4 mm
- Class II malocclusion ( bilateral class II molar relation, at least half a cusp)
Key exclusion criteria (4 listed)
- tooth agenesis
- poor oral hygiene
- previous orthodontic treatments
- systemic disease or bone pathology
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 |
|---|---|---|
| mandibular advancement with acrylic splint Herbst ApplianceMandibular advancement with acrylic splint Herbst Appliance | Procedure or surgery | skeletal anchorage, traditional anchorage |
Primary outcome
Planned mandibular advancement (mm)
Time frame: 1 year
The "planned mandibular advancement" will be evaluated on the STL of the arches by simulating a sagittal mandibular advancement , until an anterior occlusal contact will be reached
1 secondary outcome
Obtained mandibular advancement (mm)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Results publication: PubMed 28389184Manni A, Lupini D, Cozzani M. Les elastiques intermaxillaires a ancrage osseux dans une malocclusion de Classe II asymetrique : une etude de cas. Int Orthod. 2017 Jun;15(2):263-277. doi: 10.1016/j.ortho.2017.03.012. Epub 2017 Apr 25. No abstract available. French.
- Results publication: PubMed 38471383Manni A, Boggio A, Gastaldi G, Cozzani M. Is significant mandibular advancement possible after the peak of puberty? Dento-osseous palatal expansion and the STM4 technique (Skeletal Therapy Manni Telescopic Herbst 4 miniscrews): A case report. Int Orthod. 2024 Jun;22(2):100868. doi: 10.1016/j.ortho.2024.100868. Epub 2024 Mar 11.
- Results publication: PubMed 39307830Manni A, Boggio A, Caldara G, Gastaldi G, Cozzani M. Herbst appliance with four-miniscrew anchorage for mandibular advancement after the pubertal peak. J Clin Orthod. 2024 Aug;58(8):505-513. No abstract available.
- Results publication: PubMed 23814587Manni A, Pasini M, Mauro C. Comparison between Herbst appliances with or without miniscrew anchorage. Dent Res J (Isfahan). 2012 Dec;9(Suppl 2):S216-21. doi: 10.4103/1735-3327.109762.
- Results publication: PubMed 33563504Manni A, Mutinelli S, Cerruto C, Cozzani M. Influence of incisor position control on the mandibular response in growing patients with skeletal Class II malocclusion. Am J Orthod Dentofacial Orthop. 2021 May;159(5):594-603. doi: 10.1016/j.ajodo.2020.02.014. Epub 2021 Feb 7.
- Results publication: PubMed 31677670Manni A, Migliorati M, Calzolari C, Silvestrini-Biavati A. Herbst appliance anchored to miniscrews in the upper and lower arches vs standard Herbst: A pilot study. Am J Orthod Dentofacial Orthop. 2019 Nov;156(5):617-625. doi: 10.1016/j.ajodo.2018.11.015.
- Individual participant dataSharing planned: No
Related trials for Overjet
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Extraction Space Consumption and Overjet Reduction After Maxillary Anterior Enmasse Retraction in Orthodontics
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mandibular advancement with acrylic splint Herbst Appliance in people with Overjet and Class II Division 1 Malocclusion, run by IRCCS Ospedale San Raffaele 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 4 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: opening soon, as of the sponsor's last update on 23 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Boggio, DDS, PhD (+393339019030, andreaboggio90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Planned mandibular advancement (mm) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06653075, which also lists 6 linked publications.
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 23 Oct 2024.