Clinical trial NCT06967090: Accuracy of Guided Implant Placement Using Artificial Intelligence Segmentation Versus Conventional Technique
Official title: Accuracy of Guided Implant Placement Using Artificial Intelligence Segmentation Versus Conventional Technique: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Implant
Keywords: AI in guided dental implant
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the accuracy of surgical guided implant using AI tooth segmentation of the CBCT alone without intraoral scan to fabricate the implant guide versus conventional technique by alignment the CBCT and intraoral scan to fabricate the implant guide in posterior implant.

Detailed description: Background:

Implant dentistry has developed rapidly all around the world in the past few decades. A revolutionary change in the field of implant dentistry has been brought forward by Artificial intelligence (AI) technology. Many advantages come from the use of guided implant surgery and virtual implant planning, including optimal surgical and prosthetic treatment plan and predictable and effective application.

Statement of the problem:

Even with over ten years of clinical and research data, as well as advancements in apparatus and technique, there are still discrepancies between planned and achieved implant placements when using conventional guided implant surgery.

Review of literature:

Conventional guided implant surgery is considered the gold standard for implant placement as it provides a higher degree of accuracy and a lower risk of complications after surgery. Conventional guided implant surgery consists of 3 key steps. The first step is obtaining a 3D model of the manually segmented CBCT and a 3D model of the intraoral scan (IOS). The second step is alignment of the 3D model of the CBCT and the IOS by Iterative Closest Point Alignment (ICP Alignment). The third step is the virtual implant planning and surgical guide design. The segmentation is needed to create a 3D surface model from a CBCT or CT. Because of this, any error or inaccuracy in the segmentation or alignment process will lower the associated quality of virtual surgical planning.

Segmentation based on AI shows promise and saves time. This revolutionary AI-driven tool allows for precise and quick segmentation of the CBCT images. Therefore, all the steps of the conventional technique to fabricate an implant surgical guide can be less sophisticated if we use the AI segmentation alone without IOS.

Using AI tooth segmentation of the CBCT to obtain a 3D model and immediately, in one step, start virtual implant planning and designing a tooth-supported surgical guide without intraoral scan can minimize the clinical workload while opening the door for possible uses regarding digital workflows.

The outcomes of this investigation may contribute to the enhancement of pre-operative planning processes, including implant positioning and bone grafting. Still, not much has been discovered about how different segmentation techniques may affect clinical practice.

According to our knowledge there is deficiency in the literature in the evaluation of the accuracy of the AI segmentation of the CBCT when used alone in surgical implant guide without the use of intraoral scan.

Eligibility criteria: Inclusion Criteria:

1. Patients with missing posterior teeth require implant surgery.
2. Patients have remaining teeth that can support the surgical guide.
3. The edentulous area should involve healed bone sites at least 3 months after extraction.
4. The edentulous area should have bone height of at least 10 mm from the alveolar crest to the nearest vital structure and bone width of at least 6 mm.
5. Age: patient above 18 years old.
6. All patients are in good health with no systemic, immunologic or debilitating diseases that could affect normal bone healing.
7. All selected patients are non-smokers and non-alcoholics. Patients are free from temporomandibular disorders and abnormal (TMD) oral habits such as bruxism.

Exclusion Criteria:

1. Systemic disease that may affect bone quality.
2. Patients with poor oral hygiene and active periodontal diseases.
3. Patient with limited mouth opening.

Primary outcomes:
measure: The accuracy of the placed implants
timeFrame: one week after surgery
measure: Horizontal apex deviation, (Measuring unit in millimeter)
timeFrame: one week after surgery
measure: Angular deviation, (Measuring unit in degree)
timeFrame: one week after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Head of the Department of Oral & Maxillofacial Surgery Faculty of Dentistry Fayoum University
name: Haytham Ahmed Salah Al-Mahalawy, Phd
role: STUDY_CHAIR
affiliation: Lecturer of Oral & Maxillofacial Surgery Faculty of Dentistry Fayoum University
name: Nourhan Mohamed Abdelmoneim, Phd
role: STUDY_CHAIR
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