- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06910007
Accuracy of Various Advanced Treatment Planning Software for Static Computer Guided Surgery in Dental Implant
April 2, 2025 updated by: Hussein Anssari, University of Baghdad
Accuracy of Advanced Treatment Planning Software for Static Computer Guided Surgery ( Blue Sky Plan Bio, Exoplan, Real Guide Computer Software)
This study will be conducted to investigate the accuracy of Blue sky plan bio , exoplan ,and real guide advanced treatment planning software required for static computer guided surgery designing and manufacturing.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
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
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- partially edentulous adults with at least three teeth remaining.
- an expected sufficient bone volume to perform implant insertion with at least a 3.5mm Cybermed dental implant without simultaneous bone augmentation.
- extractions performed at least 3 months earlier.
- potential earlier sinus grafting was performed at least 6 months prior to implant placement.
- Patients with absence of any periodontal problems in the adjacent teeth.
7- stable medical condition to undergo implant surgery (ASA 1 or 2).
Exclusion Criteria:
- Physical or psychological disorders generally prohibiting implant therapy. After initial screening.
- Patients with a history of bruxism
- Patients with over eruption of the opposing tooth.
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: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: blue sky plan group
surgical guide will be fabricated using Blue sky plan computer software
|
dental implant will be inserted using blue sky plan computer software
surgical guide will be fabricated using exoplan computer software
surgical guide will be fabricated using real guide computer software
|
|
Active Comparator: exoplan group
surgical guide will be fabricated using Exoplan computer software
|
dental implant will be inserted using blue sky plan computer software
surgical guide will be fabricated using exoplan computer software
surgical guide will be fabricated using real guide computer software
|
|
Active Comparator: Real guide group
surgical guide will be fabricated using Real guide computer software
|
dental implant will be inserted using blue sky plan computer software
surgical guide will be fabricated using exoplan computer software
surgical guide will be fabricated using real guide computer software
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
deviation between planned and actual implant position when using different planning software
Time Frame: 14 days
|
measurement will be done by superimposition two CBCTs showing the pre-operation ( planned) and post operation implant position which will reveal the deviation in millimeter in regards to entry point ,apical ,and angular deviation of dental implant using specified tool within the planning software
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
April 20, 2025
Primary Completion (Estimated)
November 28, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
March 22, 2025
First Submitted That Met QC Criteria
April 2, 2025
First Posted (Actual)
April 4, 2025
Study Record Updates
Last Update Posted (Actual)
April 4, 2025
Last Update Submitted That Met QC Criteria
April 2, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 1025 in 11-2-2025
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
product manufactured in and exported from the U.S.
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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