Comparing Dynamic Navigation to Static Navigation in the Implant Placement (RCT)
Accuracy Assessment of Dynamic Vs. Static Navigation Implant Placement Protocols (Randomized Controlled Trial)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Ain Shams University, Faculty of Dentistry
-
Contact:
- Mohamed Wagdy Bissar, Associate Professor
- Phone Number: +2 01006687399
- Email: Mohamedwagdy.1@gmail.com
-
Contact:
- Hala Kamal Abdel Gaber, Professor
- Phone Number: +2 01222338526
- Email: Dr.halakamal@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Healthy patients at least 22 years old.
- At least one missing tooth to be restored using an implant in the upper jaw from the maxillary right 2nd premolar to the maxillary left 2nd premolar.
- At least six residual teeth in the affected jaw (5).
- Minimum of 5 mm available bone.
Exclusion Criteria:
Medical condition or medication that would impair bone healing.
- Poor oral hygiene
- Inadequate bone width or height that may need bone augmentation. 5
- Alcohol users.
- Smoking more than 10 cigarettes per day.
- History of head and neck radiotherapy.
- Pregnant females.
- Uncontrolled hypertensive or diabetic patient.
- Vulnerable group; prisoners, pregnant women, orphans…etc
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: sCAIS
|
Tooth supported guide is prefabricated before the surgery
|
|
Experimental: dCAIS
|
Dynamic navigation system called MiniNavident
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Deviation
Time Frame: Baseline, Day 0
|
Deviation in Apical position, platform position and angular deviation
|
Baseline, Day 0
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Satisfaction Questionnaire
Time Frame: 1 week
|
Patient satisfaction from procedure
|
1 week
|
|
Time
Time Frame: Perioperative/ Periprocedural
|
Operating time taken for each procedure
|
Perioperative/ Periprocedural
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 1113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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