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Clinical Trials/NCT06653075
NCT06653075Not yet recruitingNot Applicable

Role of Clinical Overjet for Mandibular Advancement: a Prospective Study

IRCCS Ospedale San Raffaele1 site in 1 country50 target enrollmentStarted: October 30, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Planned mandibular advancement (mm)

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
6 Years to 50 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

  • Obtained mandibular advancement (mm)(1 year)

Investigators

Sponsor
IRCCS Ospedale San Raffaele
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Giorgio Gastaldi

Associate Professor

IRCCS Ospedale San Raffaele

Study Sites (1)

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