- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07238335
Comparison Between Digital And Direct Pickup Of Attachments With Digitally Constructed 2-Implant Overdenture Bases
Comparative Study Between Digital Pick-up of Attachments Before Registration of Jaws Relations and Intraoral Pick-up With Digitally Constructed 2-Implant Mandibular Overdenture Bases : Peri-Implant Alveolar Bone Height Changes
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dakahlia Governorate
-
Al Mansurah, Dakahlia Governorate, Egypt, 35516
- Faculty of Dentistry Mansoura University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Upper and lower ridges covered with healthy mucosa
- Sufficient quality and quantity of alveolar bone
- Sufficient inter arch space
- Angle class one relation
Exclusion Criteria:
- Active cancer
- Immune disease
- Uncontrolled diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: digital pickup before jaw relation
|
Arm 1 - Digital Pick-up Before Jaw Relation Intervention Type: Device Description (short): Extraoral digital pick-up of ball attachments on master cast, CAD/CAM denture base fabrication, jaw relation registration, and denture insertion. |
|
Active Comparator: intraoral pickup during insertion
|
Arm 2 - Intraoral Pick-up During Insertion Intervention Type: Device Description (short): Intraoral direct pick-up of ball attachments during denture insertion after CAD/CAM denture base fabrication and jaw relation registration. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in Peri-implant marginal alveolar bone height using digital periapical radiograph at baseline (definite insertion), 6 months, ,and 12 months after insertion
Time Frame: at baseline (definite insertion), at 6 months, and after 12 months after insertion
|
at baseline (definite insertion), at 6 months, and after 12 months after insertion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: mohamed m foaud, phd, faculty of dentistry Mansoura university removable Prosthodontics department
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
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
Other Study ID Numbers
- A05010023RP
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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