Clinical trial NCT06135506: Artificial Intelligence/Computer Guided Ridge Splitting for Treating Horizontal Ridge Defects
Official title: Artificial Intelligence-Assisted/Computer Guided Ridge Splitting for the Treatment of Horizontal Ridge Defects With Simultaneous Guided Implant Placement: Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Resorption
Dental Implant Failure Nos
Keywords: Artificial intelligence
ridge splitting
computer-guided surgery
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided ridge splitting approach assisted by artificial intelligence versus conventional approach combined with simultaneous implant Placement.

Detailed description: Ridge split technique is considered one of the successful horizontal bone augmentation procedures especially in maxilla for the management of horizontal ridge defects. This was adapted by Summers in 1994.

Guided implant surgery was used in dental implant surgery to achieve accuracy and an overall predictability. Successful guided implant workflow depends on 3-dimensional image acquisition and precise model fabrication.

Artificial intelligence application in implant dentistry has ushered in a new era of precision and efficiency demonstrating improved implant survival rates and patient satisfaction and enhance the integration of technologies with digital workflows.

Eligibility criteria: Inclusion Criteria:

* The target population with inadequate bone volume for implant placement due to width insufficiency of maxillary anterior alveolar ridges.
* Age ranges from 25-40 years of both sexes.
* No gender restrictions were considered for initial screening.
* Absence of any complicating systemic condition that may contraindicate surgical procedures and implant placement.
* Adequate oral hygiene.
* Eligible participants should present good general health and agree to random assignment to any of the two parallel study groups.
* Participants had minimum 3 months as post extraction healing period and horizontal maxillary anterior ridge defects with at least bone width of 3 mm and bone height of 13 mm.

Exclusion Criteria:

* Vertical ridge defect.
* Undercut on the labial/buccal side.
* Thick cortical bone without cancellous bone inside.
* Uncontrolled systematic disorders as, diabetes mellitus, uncontrolled periodontal disease, history of head and neck radiotherapy, smokers, pregnancy, noncompliant patients, allergy to the used medications, uncooperative individuals or those unable to attend the study follow-up appointments.

Primary outcomes:
measure: alveolar ridge width
timeFrame: 9-month.
Secondary outcomes:
measure: vertical bone height
timeFrame: 9-months
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Walid Elamrousy
Study officials:
References: