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Not yet recruiting NCT06653075

Mandibular Advancement Planning Based on Clinical Overjet

No phase Interventional Overjet Class II Division 1 Malocclusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mandibular advancement with acrylic splint Herbst Appliance.
Who it may be relevant to
Registry conditions: Overjet, Class II Division 1 Malocclusion. Basic parameters: 6 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Role of Clinical Overjet for Mandibular Advancement: a Prospective Study

Overview

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

Interventions

  • Procedure mandibular advancement with acrylic splint Herbst Appliance
    Mandibular advancement with acrylic splint Herbst Appliance

Primary outcome measures

  • Planned mandibular advancement (mm) [Time frame: 1 year]
Secondary outcome measures (1)
  • Obtained mandibular advancement (mm) [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Vita-Salute San Raffaele University — Milan

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. PMID 28389184
  • 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 38471383
  • 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 39307830
  • 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 23814587
  • 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 33563504
  • 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 31677670

Identifiers

NCT: NCT06653075 · OJ2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗