Back to resultsAccuracy of Conventional and Digital Impression Techniques Used for Maxillary Hybrid Prosthesis
Primary Purpose
Prosthesis Durability
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
impression techniques for implant used for maxillary screw retained hybrid prosthesis
Sponsored by
About this trial
This is an interventional other trial for Prosthesis Durability focused on measuring digital impression, conventional impression
Eligibility Criteria
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.
Sites / Locations
- faculty of Dentistry , Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
technique 1: conventional splinted open tray impression
technique 2: digital intraoral impression technique
Arm Description
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.
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)
Outcomes
Primary Outcome Measures
accuracy of impression technique
deviation measurements digitally
Secondary Outcome Measures
passivity of final restoration
Clinical measurement of prosthesis passivity using single screw test of Sheffield.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05321589
Brief Title
Accuracy of Conventional and Digital Impression Techniques Used for Maxillary Hybrid Prosthesis
Official Title
Accuracy of Digital and Conventional Impression Techniques for Maxillary Full Arch Screw Retained Hybrid Prosthesis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
February 20, 2022 (Actual)
Study Completion Date
March 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
evaluation and comparison of the accuracy of conventional and digital impression for full arch screw retained prosthesis for edentulous maxilla.
Detailed Description
Each patient received 6 implants in the maxillary ridge (widely distributed across the arch) in the following positions: central incisors, canines/first premolar teeth and first molar teeth aided by surgical stent. then each patient received 2 types of impression techniques Technique 1 :conventional impression conventional open tray impression technique with splinted transfers using vinylpolysiloxane and Technique2 : Digital impression taken using original scan bodies torqued to the implants .three dimensional accuracy of impression techniques was evaluated using linear measurements and 3D deviation between the two techniques was measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis Durability
Keywords
digital impression, conventional impression
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
the conventional open tray splinted impression technique and the digital intraoral impression technique were done for each patient
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
technique 1: conventional splinted open tray impression
Arm Type
Other
Arm Description
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.
Arm Title
technique 2: digital intraoral impression technique
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
impression techniques for implant used for maxillary screw retained hybrid prosthesis
Other Intervention Name(s)
digital and conventional impression techniques
Intervention Description
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
Primary Outcome Measure Information:
Title
accuracy of impression technique
Description
deviation measurements digitally
Time Frame
immediately after the intervention/procedure
Secondary Outcome Measure Information:
Title
passivity of final restoration
Description
Clinical measurement of prosthesis passivity using single screw test of Sheffield.
Time Frame
immediately after the intervention/procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
faculty of Dentistry , Mansoura University
City
Mansoura
State/Province
DK
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Accuracy of Conventional and Digital Impression Techniques Used for Maxillary Hybrid Prosthesis
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