Mandibular Advancement Planning Based on Clinical Overjet

NCT ID: NCT06653075

Last Updated: 2024-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-30

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overjet Class II Division 1 Malocclusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

traditional anchorage

Skeletal class II patients treated by Herbst Appliance with traditional dental anchorage

Group Type ACTIVE_COMPARATOR

mandibular advancement with acrylic splint Herbst Appliance

Intervention Type PROCEDURE

Mandibular advancement with acrylic splint Herbst Appliance

skeletal anchorage

Skeletal class II patients treated by Herbst Appliance with skeletal anchorage

Group Type EXPERIMENTAL

mandibular advancement with acrylic splint Herbst Appliance

Intervention Type PROCEDURE

Mandibular advancement with acrylic splint Herbst Appliance

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mandibular advancement with acrylic splint Herbst Appliance

Mandibular advancement with acrylic splint Herbst Appliance

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ANB\>=4°
* Overjet \>=4 mm
* Class II malocclusion ( bilateral class II molar relation, at least half a cusp)

Exclusion Criteria

* tooth agenesis
* poor oral hygiene
* previous orthodontic treatments
* systemic disease or bone pathology
Minimum Eligible Age

6 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

IRCCS Ospedale San Raffaele

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Giorgio Gastaldi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vita-Salute San Raffaele University

Milan, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Andrea Boggio, DDS, PhD

Role: CONTACT

+393339019030

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Giorgio Gastaldi, DM,DDS

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 28389184 (View on PubMed)

Manni 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.

Reference Type RESULT
PMID: 38471383 (View on PubMed)

Manni 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.

Reference Type RESULT
PMID: 39307830 (View on PubMed)

Manni 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.

Reference Type RESULT
PMID: 23814587 (View on PubMed)

Manni 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.

Reference Type RESULT
PMID: 33563504 (View on PubMed)

Manni 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.

Reference Type RESULT
PMID: 31677670 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OJ2024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.