Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05471024 |
| Other study ID # |
KADY0001 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
July 27, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Regardless of the fabrication workflow occlusal adjustments seem to be inevitable during
delivery of indirect fabrication of the restoration. This has been attributed to snowballing
of discrepancies due to multiple procedures for information transfer between the clinician
and the laboratory. Current digital workflows minimize these discrepancies due to digital
acquisition technology which eliminates drawbacks from physical materials which would alter
the dimensions and morphology of the final restoration. Utilizing 3D face scanning technology
is by far the least invasive and the least time consuming of available virtual facebow
techniques and thus it's utilization could offer the benefit of saving time during occlusal
adjustment and enhanced strength of the restoration by not subjecting it to the heat
generation and subsequent crack initiation which occurs during occlusal adjustment. This
study aims to compare the effect of a face scan to alignment of the maxillary cast on the
volume and time of occlusal adjustment compared to conventional articulator digitization to
align the maxillary cast.
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
1. Proximal contour and contact.
2. Marginal integrity
3. Facial and lingual contours.
4. Surface finish.
5. Color and shade.
Impression prior to occlusal adjustment, Occlusal adjustment, Timing occlusal adjustment
procedure, Impression after occlusal adjustment, Cementation.
