Clinical trial NCT06653075: Mandibular Advancement Planning Based on Clinical Overjet
Official title: Role of Clinical Overjet for Mandibular Advancement: a Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Overjet
Class II Division 1 Malocclusion
Lead sponsor: IRCCS Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Planned mandibular advancement (mm)
timeFrame: 1 year
Secondary outcomes:
measure: Obtained mandibular advancement (mm)
timeFrame: 1 year
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Vita-Salute San Raffaele University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.