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Clinical Trials/NCT06168279
NCT06168279UnknownNot Applicable

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

Cairo University1 site in 1 country18 target enrollmentStarted: February 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
18
Locations
1
Primary Endpoint
accuracy of occlusal registration

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

conventional group

Active Comparator

hand occlusal articulation

Intervention: hand occlusal articulation (Procedure)

study group

Active Comparator

digital occlusal articulation

Intervention: digital occlusal articulation (Procedure)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

abdullah gamal abdullah alawlaqi

phd candidate and principal investigator

Cairo University

Study Sites (1)

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