- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06272474
Virtual Reproduction of Mandibular Movement for Assessing Occlusal Interferences and Adjustments
Reliability of Virtual Reproduction of Mandibular Movement for Assessing Occlusal Interferences and Adjustments of Designed and Milled Cad-cam Zirconia Crowns; a Diagnostic Accuracy Trial
Computer-aided designs have considered dynamic occlusion with virtual articulator systems. However, the process involved is currently lengthy. The simplified transfer of casts from a mechanical to a virtual articulator has required bulky and expensive instruments. Recently, new methods based on mandibular motion tracking using optical devices have been introduced for integrating individual functional movement into occlusal morphology.
The aim of this study: This study will clinically assess the reliability of the virtual reproduction of mandibular movement for detecting occlusal interferences and adjustments of designed and milled CAD-CAM zirconia crowns using a digital occlusal analyzer.
Materials and methods: Intraoral optical impression will be made for thirteen selected patients with endodontically treated maxillary first premolars after abutment preparation followed by buccal and lateral interocclusal records taking. Two zirconia crowns will be fabricated for each patient following regular digital workflow with twenty six zirconia crowns, which will be allocated according to the virtual method of adjustment of occlusal interferences into two groups (Group I: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal interocclusal record (n=13) and Group II: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal and lateral interocclusal records (n=13)). Then milling and sintering of all crowns will be performed following the manufacturer's instructions. The occlusion of all crowns will be analyzed using an electronic pressure analyzer. All data will be statistically analyzed and discussed in light of the results obtained.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Alexandria, Egypt
- Alexandria Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
The patient presented with successful endodontically treated maxillary 1st premolar.
- Patients having class I occlusion.
- Good oral hygiene with no signs of periapical pathology or periodontal disease(24).
- Patient having natural teeth as opposed to dentition.
Exclusion Criteria:
- Pregnancy, which prevents the use of diagnostic x-rays.
- Parafunctional habits.
- Mobility in the abutment teeth more than grade 1.
- Patient presenting allergy to materials being used.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Buccal interocclusal records
|
Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal interocclusal record. First, scanning the buccal interocclusal record for each patient with the two arches in maximum intercuspation position (MIP) will be performed. The IOS will immediately reproduce the occlusal state of the digital casts; this method is called the buccal bite registration method (BBR). |
|
Experimental: Lateral interocclusal records
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Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using lateral interocclusal record. A second scan will be performed for each patient to record lateral mandibular excursion. Then, three STL files will be exported; maxillary arch, mandibular arch at MIP and lateral mandibular excursion |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Static occlusal interference
Time Frame: Through study completion, average 12 months
|
it is measured at patient's maximum intercuspation using occlusense device
|
Through study completion, average 12 months
|
|
Dynamic occlusal interference
Time Frame: Through study completion, average 12 months
|
it is measured at patient's lateral mandibular movement using occlusense device
|
Through study completion, average 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0266-07/2021 - 18/07/2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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