Mandibular Advancement Planning Based on Clinical Overjet

October 21, 2024 updated by: Giorgio Gastaldi, IRCCS Ospedale San Raffaele

Role of Clinical Overjet for Mandibular Advancement: a Prospective Study

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: traditional anchorage
Skeletal class II patients treated by Herbst Appliance with traditional dental anchorage
Procedure: mandibular advancement with acrylic splint Herbst Appliance
Mandibular advancement with acrylic splint Herbst Appliance
Experimental: skeletal anchorage
Skeletal class II patients treated by Herbst Appliance with skeletal anchorage
Procedure: mandibular advancement with acrylic splint Herbst Appliance
Mandibular advancement with acrylic splint Herbst Appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Ospedale San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

October 17, 2024

First Submitted That Met QC Criteria

October 19, 2024

First Posted (Actual)

October 22, 2024

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OJ2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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