- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05750004
Deviation Between Virtual and Actual Computer Guided Immediate Implants Using the New Safe Angle Position Concept
The Deviation Between the Planned and Actual Positions of Immediate Implants Placed in the Anterior Maxilla Using the Virtual Safe Angle Concept and a Novel Computer-guided Drilling Protocol. A Prospective Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- International Dental Contining Education Centre (IDCE)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults ≥ 20 years to 50 years of both genders and in good general health.
- Maxillary anterior tooth that cannot be retained due to non-periodontitis, including fracture, endodontic failure, and root resorption, bounded by natural teeth.
- Intact buccal bone plate (via CBCT).
- The extraction socket has at least 3-5 mm apical bone.
Exclusion Criteria:
1. Smokers 2. Pregnant and lactating females: Pregnancy as this will limit recording the outcome data eg: CBCT.
3. Medically compromised patients, as uncontrolled diabetic patients, patients taking bisphosphonates injection for treatment of osteoporosis, patients with active cardiac diseases, patients undergoing radiotherapy or chemotherapy, or any other medical and general contraindications for the surgical procedure (i.e. ASA score ≥III) (31) 4. Patients with active infection related at the site of implant/bone graft placement.
5. Patients with untreated active periodontal diseases. 6. Patients with parafunctional habits. 7. Refuse to participate in this study.
Study Plan
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 |
|---|---|
|
Experimental: Computer guided immediate implant placement
Atraumatic extraction followed by immediate implant placement using safe angle position computer guided surgical stents.
|
Atraumatic extraction followed by immediate implant placement using safe angle position computer guided surgical stents, followed by customized healing abutments.
after 3 months, Impressions for final prosthesis will be done
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Angular deviations
Time Frame: 9 months
|
Angular discrepancy (measured in degrees) be-tween the planned and actual implant position respective to the center of the implant body.
It is primarily ascribed to a variation in point of implant entry
|
9 months
|
Collaborators and Investigators
Sponsor
Collaborators
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
Other Study ID Numbers
- OSA3231001
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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