Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06067334 |
| Other study ID # |
J0104023RP |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 20, 2023 |
| Est. completion date |
July 20, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Mansoura University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
aim: to compare the accuracy of the conventional and digital impression when will be
performed on implant level or abutment level in Complete digital workflow for construction of
full arch implant supported screw-retained restoration.
Description:
The patient will be selected according to the following criteria:
1. Free from any systemic disease that may interfere with proper Osseointegration of
implants, which will be assessed by thorough medical investigations.
2. Patients having completely edentulous maxilla and mandible for at least 6 months after
the last extraction.
3. Normal maxilla mandibular relationship with adequate inter-arch space, measured by
tentative jaw relation.
4. Sufficient residual alveolar ridge.
Exclusion criteria include:
1. Local or general contraindications for surgical procedures.
2. Patients with TMJ disorders or poor neuromuscular coordination or parafunctional habits.
3. Severe inter-maxillary skeletal discrepancy or limited inter-arch space.
4. Heavy smokers.
- For all patients, conventional complete dentures are constructed.
- Implants installed in the edentulous maxilla and mandible in each target position
guided by stereolithographic stent. A delayed loading protocol is followed in this
study.
- After osseointegration, a conventional open tray splinted impression technique will
be made for each patient on the implant/abutment level.
- Scan bodies' implant level/abutment level will be tightened for each patient, and a
digital intraoral scanner will be used to scan the scan bodies for making implant
level/abutment level digital impressions.
Accuracy will be evaluated as follows:
- 3D inspection software using the best-fit alignment algorithm will be utilized to
calculate the 3D deviation of each impression using the root mean square (RMS) error.
- Passive fit of the framework will be evaluated at the time of insertion.
