- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05948254
Utilized Scan Body Technique For Triple Function
July 10, 2023 updated by: Ain Shams University
Utilized Scan Body Technique For Jaw Relation Registration And Face Scan Alignment (Triple Function Scan Body)
A triple function scan Body were done on healed dental implant, thus simplifying the workflow for full arch cases and reducing the number of visits to only 3 visits.
In this technique, scan bodies were utilized for implant position scanning, facial scan alignment and as stoppers for jaw relation capturing as scan bodies were used as stoppers for jaw relation registration.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The present article describes a novel technique for merging a patient's facial scan with implant scan body and in the same time utilizing the same scan body for recording the jaw relation in only one visit.
As a result, a facially driven full-arch implant-supported interim prosthesis can be fabricated first followed by the final restoration in a simplified approach.
The aim of this study is to determine whether there is a difference between virtual design and reality using scan body technique (triple function scan body which reflects the accuracy of the scanning protocol.
The null hypothesis established that there was consistency between the virtual design and prosthesis in patient's mouth.
The scan body was placed in the edentulous arch in the jaw scan step so that bite registration would be easier for the intraoral scanner (IOS) in order to be able to capture both the teeth of the antagonist and part of the scan body in the edentulous jaw simultaneously.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Abbassia
-
Cairo, Abbassia, Egypt, 11566
- Ain Shams University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- patient had at least one edentulous arch with at least 5 osseointegrated implants with healing period of 3 months after surgical procedure.
- Implants are stable
- Systemically free
Exclusion Criteria:
- Smokers
- Uncooperative patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Triple Function Scan Body
Full arch implants were placed, a triple function scan Body and thus simplifying the workflow for full arch cases and reducing the number of visits to only 3 visits.
Scan bodies were utilized for implant position scanning, facial scan alignment and as stoppers for jaw relation capturing as scan bodies were used as stoppers for jaw relation registration.
|
The scan bodies were used to scan the implant position, Jaw registration and facial scan alignment, First of all scan bodies were selected according to vertical dimension of occlusion, then the emergence profile together with the selected scan body were scanned,All scan bodies were then removed from the patient mouth except one or even two that were scanned in the jaw scan step, this scan body was utilized as a stopper, the patient was asked to bite until the scan body came in contact with the lower or upper teeth in case of edentulous upper or lower arch respectively, scan body in place (in the same orientation of the previous jaw scan ) provided that at least the tip of the scan body appeared when the patient is asked to smile which would be used as a common area so that the intra oral scanner can relate the jaw scan to the lips and face.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
percentage of consistency in simultaneous contacts in maximal intercuspal position
Time Frame: 2 months following the final prosthesis
|
At 2 months follow up after final prostheses delivery, a frontal photo was taken and an intra oral scan was made for each patient in order to assess the degree of consistency between initial virtual design and reality using Exocad Software, The intra oral Scan of the full arch restoration is inserted into Exocad Software and the interocclusal contacts for all teeth were detected, classifying them in a dichotomy variable (yes/no) contact or not per tooth.
|
2 months following the final prosthesis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Doaa Adel-Khattab, PhD, Associate Professor Faculty of Dentistry, Ain Shams University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 11, 2022
Primary Completion (Actual)
April 24, 2023
Study Completion (Actual)
May 31, 2023
Study Registration Dates
First Submitted
July 10, 2023
First Submitted That Met QC Criteria
July 10, 2023
First Posted (Actual)
July 17, 2023
Study Record Updates
Last Update Posted (Actual)
July 17, 2023
Last Update Submitted That Met QC Criteria
July 10, 2023
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 245862
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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