Virtual Digital Articulation Versus Hand-articulation Accuracy for Occlusal Registration in Orthognathic Surgery

May 13, 2024 updated by: abdullah gamal abdullah alawlaqi, Cairo University

Assessment of Virtual Digital Articulation Versus Hand-articulation Accuracy for Occlusal Registration in Orthognathic Surgery (Randomized Clinical Trial)

Conventionally, orthognathic occlusal planning is performed by physically articulating the study models until a well interdigitated occlusion is achieved. this is undertaken in conjunction with the analysis of the face and jaw bones for surgical planning.

Computer-assisted planning now allows digital planning of orthognathic surgery, including assessment of the quality of the final occlusion and printing of the guiding occlusal wafers. This can be achieved through the replacement of the defective images of the dentition produced by the cone beam computed tomography (CBCT) scan with accurate digital images of the study models, captured using CBCT or laser scanning

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The determination of an ideal dental occlusion is a vital step in planning orthognathic surgery. Conventionally, a dental occlusion is determined using model surgery based on two dimensional cephalometric planning for the movement of maxillary and mandibular segments. Later, acrylic surgical splints were fabricated in the articulator and used in operating rooms to reposition jaw bones. This conventional method is well established, widely used, and inexpensive. However, its main disadvantages are that patients experience discomfort during the impression procedure, and making dental models and performing model surgery are time consuming. In addition, there is a need for storing dental casts, and errors may occur during this procedure. Computer-aided simulation surgery and three-dimensional planning have become popular. Nadjmi et al. proposed an experimental method for virtual occlusions and demonstrated that the mean distance between their conventional and virtual manual occlusion was small. Adolphs et al. scanned a dental cast and aligned the tooth image for a virtual occlusion by using a software program and reported no difference between the virtual and traditional splint when fitted to a patient's dentition. Wu et al. proposed an experimental haptic simulation framework to determine the virtual occlusion in digital models and showed that the translation and angular deviation of virtual results were smaller compared with the benchmark. However, because the conventional dental impression and model are still required in the computer-aided system and the occlusion setup is determined by the dental model, it cannot be described as fully digital three dimensional planning.

Intraoral digital scanning is an innovative dental technology that has advanced the field of prosthodontics and orthodontics. This technique has been introduced as an alternative to the conventional method for scanning patients' dentition and has become a convenient method for digital impression and model fabrication.The scans can be imported to a software program for planning orthodontic treatment. However, the use of intraoral scanning for the digital setup of the final dental occlusion in three-dimensional orthognathic surgery planning has not yet been reported.

Study Type

Interventional

Enrollment (Estimated)

18

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 Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Abdullah
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age arrange from 18-40 yr
  • Patient requiring orthognathic surgery to correct dentofacial occlusion deformity
  • Patient should be free from any significant medical condition that could affect healing or outcomes

Exclusion Criteria:

  • • One or more missing central incisors, canines, and/or first molars

    • Patient with facial cleft
    • Patient with significant medical condition

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional group
hand occlusal articulation
Procedure: hand occlusal articulation
The upper and lower cast will be scanning separately then will be articulated manually in the final occlusion then scanned after that the stl file will insert to the software to complete virtual planning of orthognathic surgery to made splints that will be using in the operation
Active Comparator: study group
digital occlusal articulation
Procedure: digital occlusal articulation
Both upper and lower casts will be scanning separately, then the 3D casts will be articulating by using 3d virtual program to obtained the final occlusion after that the stl file will insert to the software to complete virtual planning of orthognathic surgery to made splints that will be using in the operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy of occlusal registration
Time Frame: immediate after one month of procedure

The study will be comparing accuracy in occlusal registration ( between peroperative occlusal registration and postoperative occlusal registration ) between the two groups conventional (hand occlusal articulation) and study group (digital virtual occlusal articulation)

accuracy will be assessed through measuring difference between preoperative and postoperative in software using reference points. measurement will be in millimeters
immediate after one month of procedure

Collaborators and Investigators

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

Sponsor

Cairo University

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 (Actual)

February 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

November 25, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • omfs 337

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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