- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05471024
Occlusal Adjustment Time and Volume for Single Unit Fixed Prosthesis Fabricated With Different Virtual Mounting
Intraoral Occlusal Adjustment Time and Volume Required for Single Unit Fixed Prosthesis Fabricated With Different Virtual Articulator Mounting Methods (a Randomized Controlled Clinical Trial)
Study Overview
Status
Conditions
Detailed Description
This study will be carried out on participants enrolled at the outpatient fixed prosthodontics clinic, Faculty of Dentistry, Cairo University.
Digital face scanning technology has made it possible to align the maxillary cast in a virtual articulator to represent a more accurate relationship to the terminal hinge axis of the patient than average positioning on a virtual Bonwill triangle. This would be reflected on the occlusal design of the restoration and subsequently on the amount of adjustment needed to the occlusal surface of the restoration during delivery. Decreasing the amount and time of occlusal adjustment would result in a decrease in chair time, increase in the longevity of the restoration and enhanced esthetics of the restoration.
Conventional alignment and mounting of casts to simulate the patients' dynamic occlusions remains the gold standard to which newer digital cast alignment and relation technology is to be compared. Thus the selection of the articulator scan as the comparator was made
Participants' Timeline
Clinical Visit 1 Preoperative records Clinical examination, Radiographic examination, Assessment of inclusion, Informed consent, Intraoral photographs, Primary impression (irreversible hydrocolloid) for diagnostic cast fabrication.
Clinical Visit 2 Facebow record, Articulator mounting, Face Scan, Foundation restoration for participant tooth built to full contour.
Clinical Visit 3 Preparation, Impression, Provisionalisation,
Allocation Impartial third party randomly allocates jaw relation methods to participants and informs laboratory technician of allocation results.
Single unit fixed prosthesis will be fabricated as per allocation results
Clinical Visit 4 Checking and verification of restoration ensuring
- Proximal contour and contact.
- Marginal integrity
- Facial and lingual contours.
- Surface finish.
- Color and shade.
Impression prior to occlusal adjustment, Occlusal adjustment, Timing occlusal adjustment procedure, Impression after occlusal adjustment, Cementation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt
- Faculty of Dentistry, Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be aged 21-70 years old, be able to read and sign the informed consent document.
- Psychologically and physically able to withstand conventional dental procedures.
Participants with molars indicated for full coverage restorations
- Large carious lesions
- Teeth restored with large restorations
- Endodontically treated teeth
- Accept to undergo face scanning and articulator mounting procedures
- Have no active periodontal or pulpal diseases, have teeth with clinically acceptable restorations.
- Able to attend punctually for preplanned visits and evaluation.
Exclusion Criteria:
- Participants with active resistant periodontal diseases.
- Participants with poor oral hygiene, high caries risk and uncooperative participants.
- Pregnant women.
- Participants in the growth stage with partially erupted teeth.
- Psychiatric problems or unrealistic expectations.
- Lack of opposing dentition in the area of interest.
- Restored occlusal surface opposing the planned restoration.
- The presence of a removable or fixed orthodontic appliance.
- Signs of bruxism or clenching
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Digitized Mounted Articulator Scan
Conventional articulator facebow mounting will be digitized using extraoral digital 3d scanner and used to position the maxillary cast on the virtual articulator. This positioning will be utilized during design of the occlusal surface of the restoration. |
Conventional articulator facebow mounting will be digitized using extraoral digital 3d scanner and used to position the maxillary cast on the virtual articulator.
This positioning will be utilized during design of the occlusal surface of the restoration.
|
|
Experimental: Average Positioning on Virtual Bonwill Triangle
Virtual Bonwill triangle will be used to position the maxillary cast on the virtual articulator. This positioning will be utilized during design of the occlusal surface of the restoration. |
Virtual Bonwill triangle will be used to position the maxillary cast on the virtual articulator. This positioning will be utilized during design of the occlusal surface of the restoration. |
|
Experimental: Digital Face Scan
Digital face scan will be used to position the maxillary cast on the virtual articulator. This positioning will be utilized during design of the occlusal surface of the restoration. |
Digital face scan will be used to position the maxillary cast on the virtual articulator. This positioning will be utilized during design of the occlusal surface of the restoration. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Occlusal Adjustment Time
Time Frame: Immediately after verification of restoration acceptability but prior to occlusal adjustment. Time will be measured until occlusal contacts of the crown have been harmonized during the delivery clinical visit.
|
Time taken to harmonize occlusal contacts with participants masticatory function during delivery of the crown.Measured in minutes and seconds.
|
Immediately after verification of restoration acceptability but prior to occlusal adjustment. Time will be measured until occlusal contacts of the crown have been harmonized during the delivery clinical visit.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Volume of Occlusal Adjustment
Time Frame: Before and immediately after the occlusal adjustment. Volume before occlusal adjustment - volume after occlusal adjustment of the of the crown = volume difference
|
Amount of material removed from occlusal surface of restoration to harmonize occlusal contacts during delivery of the crown with participants masticatory function.
|
Before and immediately after the occlusal adjustment. Volume before occlusal adjustment - volume after occlusal adjustment of the of the crown = volume difference
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aly AM El-Kady, MSc, Fixed Prosthodontics Department, Misr International University
- Study Chair: Shereen A Ameen, Prof. Dr., Fixed Prosthodontics Department, Cairo University
- Study Director: Rasha NM Sami, Prof. Dr., Fixed Prosthodontics Department, Cairo University
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- KADY0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Clinical Trials on Crowns
-
Universitat Internacional de CatalunyaCompleted
-
British University In EgyptRecruiting
-
Armed Forces Institute of Dentistry, PakistanNot yet recruiting
-
Hiroko NagaokaTerminatedCrowns | DentureUnited States
-
Damascus UniversityCompleted
-
Ain Shams UniversityActive, not recruiting
-
Damascus UniversityRecruitingCrowns | Tooth PreparationSyrian Arab Republic
-
University of ZurichITI FoundationActive, not recruitingImplant-supported Single CrownsSwitzerland
-
Armed Forces Institute of Dentistry, PakistanNot yet recruitingZirconia Crowns | Proximal ContactsPakistan
-
University of ZurichCompletedImplant-supported Single CrownsSwitzerland