NCT06653075

Brief 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 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

October 30, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

October 17, 2024

Last Update Submit

October 21, 2024

Conditions

OverjetClass II Division 1 Malocclusion

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (1)

  • Obtained mandibular advancement (mm)

    1 year

Study Arms (2)

traditional anchorage

ACTIVE COMPARATOR

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

Procedure: mandibular advancement with acrylic splint Herbst Appliance

skeletal anchorage

EXPERIMENTAL

Skeletal class II patients treated by Herbst Appliance with skeletal anchorage

Procedure: mandibular advancement with acrylic splint Herbst Appliance

Interventions

mandibular advancement with acrylic splint Herbst AppliancePROCEDURE

Mandibular advancement with acrylic splint Herbst Appliance

skeletal anchoragetraditional anchorage

Eligibility Criteria

Age6 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • tooth agenesis
  • poor oral hygiene
  • previous orthodontic treatments
  • systemic disease or bone pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vita-Salute San Raffaele University

Milan, Italy

Location

Related Publications (6)

  • 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.

    PMID: 28389184RESULT

  • 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.

    PMID: 38471383RESULT

  • 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.

    PMID: 39307830RESULT

  • 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.

    PMID: 23814587RESULT

  • 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.

    PMID: 33563504RESULT

  • 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.

    PMID: 31677670RESULT

MeSH Terms

Conditions

OverbiteMalocclusion, Angle Class II

Interventions

Mandibular Advancement

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistryOrthodontics

Central Study Contacts

Andrea Boggio, DDS, PhD

CONTACT

+393339019030andreaboggio90@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 17, 2024

First Posted

October 22, 2024

Study Start

October 30, 2024

Primary Completion

December 30, 2024

Study Completion

December 30, 2025

Last Updated

October 23, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)