- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05321589
Accuracy of Conventional and Digital Impression Techniques Used for Maxillary Hybrid Prosthesis
Accuracy of Digital and Conventional Impression Techniques for Maxillary Full Arch Screw Retained Hybrid Prosthesis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
DK
-
Mansoura, DK, Egypt, 35516
- Faculty of dentistry , Mansoura university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
The patients were selected according to the following inclusion criteria:
- Completely edentulous maxillary and mandibular ridges
- Healthy ridge covered by normal oral mucosa and free from any ridge flabbiness.
- All of the patients were dissatisfied with the retention and stability of their maxillary conventional dentures and expressed a strong desire for a more stable prosthesis.
- Sufficient bone quantity and quality in the front and posterior maxillary regions, as determined by preoperative CBCT, to accommodate six implants with a diameter of at least 3.5 mm and a length of at least 10 mm.
- Enough restorative space (from the mucosa covering the crest of the maxillary residual ridge to the occlusal plane) to allow the fixed prosthesis to be constructed ,preliminary jaw relationship revealed this.
It's been at least a year since the last extraction.
Exclusion Criteria:
- Systemic diseases that may alter tissue response to implantation and affects osseointegration (radiation, diabetes, osteoporosis, bleeding disorders or hepatic patients)
- Long term immunosuppressive and corticosteroid drug therapy.
- Patient with abnormal habits as clenching and bruxism.
- Smoking patients.
- Patients with problems in TMJ.
- Neuromuscular diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: technique 1: conventional splinted open tray impression
a conventional open tray impression technique splinted with ligature wire and duralay resin was done with polyvinyl siloxane impression . analogues were screwed to the impression copings and casts were poured. |
conventional splinted open tray impression technique was done for maxillary implants to fabricate screw retained hybrid prosthesis and digital intra oral impression was done for the same patients after screwing scan bodies to the implants intra orally. evaluation of accuracy and 3D deviation between the two techniques was done
Other Names:
|
|
OTHER: technique 2: digital intraoral impression technique
scan bodies were screwed to implants intraorally and digital scanner was used to record digital impression, scanning protocol started from occlusal ,buccal to palatal surfaces. The resulting scans were then exported in the standard tessellation format (.STL) |
conventional splinted open tray impression technique was done for maxillary implants to fabricate screw retained hybrid prosthesis and digital intra oral impression was done for the same patients after screwing scan bodies to the implants intra orally. evaluation of accuracy and 3D deviation between the two techniques was done
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
accuracy of impression technique
Time Frame: immediately after the intervention/procedure
|
deviation measurements digitally
|
immediately after the intervention/procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
passivity of final restoration
Time Frame: immediately after the intervention/procedure
|
Clinical measurement of prosthesis passivity using single screw test of Sheffield.
|
immediately after the intervention/procedure
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- A25100221
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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