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NCT Number: NCT06653075

Mandibular Advancement Planning Based on Clinical Overjet

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

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Key information

Age range

6 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vita-Salute San Raffaele University

Milan, Italy

Location contact

Giorgio Gastaldi, DM,DDS

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mandibular advancement with acrylic splint Herbst Appliance

Procedure

Mandibular advancement with acrylic splint Herbst Appliance

Primary outcomes

  1. 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

Secondary outcomes

  1. Obtained mandibular advancement (mm)

    Time frame: 1 year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Boggio, DDS, PhD

CONTACT

[email protected]

+393339019030

Sponsors and collaborators

Lead sponsor

IRCCS Ospedale San Raffaele

Other

Registry information

Official study title

Role of Clinical Overjet for Mandibular Advancement: a Prospective Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 22, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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