Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases

NCT07891442 | Not Yet Recruiting

• 1 other identifier: 4646
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare the accuracy and clinical performance of artificial intelligence (AI)-assisted implant planning with conventional human-based implant planning in patients presenting with free-end saddle edentulous areas requiring dental implant rehabilitation. Preoperative cone-beam computed tomography (CBCT) images and intraoral scans will be used to assess the available bone, anatomical landmarks, and prosthetically driven implant positions. Implant planning and surgical guide fabrication will be performed using standardized digital workflows under the supervision of an experienced implant planning specialist. Postoperative CBCT imaging will be used to evaluate deviations between the planned and actual implant positions. The study will assess the accuracy of both planning approaches to determine whether AI-assisted planning provides comparable or improved implant placement accuracy relative to conventional planning.

Conditions

Partial Edentulism Class 1 or Class 2

Keywords

Dental implant - Surgical guide - Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• 3D deviation.

  By using surface-based registration, the postoperative CBCT will be super imposed onto the preoperative CBCT, which contains the virtual implant planned position. One operator will conduct all measurements by means of the treatment evaluation module of the software, calculating the 3D deviation of the implant platform, apex, and angle between the planned and placed positions.

  1 month

Study Arms (2)

Arm 1: control group

SHAM COMPARATOR

patients in this arm will receive implant therapy using conventionally planned, human-assisted surgical guide.

Procedure: Dental implant palcement

Arm 2: test group

ACTIVE COMPARATOR

patients in this arm will receive implant therapy using a surgical guide produced through an AI-assisted implant planning workflow. The AI-generated treatment plan and surgical guide design will be reviewed, verified, and approved prior to guide fabrication and surgical implementation.

Procedure: Dental implant palcement

Interventions

Dental implant palcement PROCEDURE

* All surgical procedures will be performed by the same operator. Prior to surgery patient will be instructed to rinse with 0.1% chlorhexidine gluconate for 30 seconds. * Anesthesia will be obtained by administration of 2% lidocaine 1:80,000 epinephrine. * In both study groups, the surgical guides will be clinically evaluated prior to surgery to ensure accurate fit, complete seating, and adequate stability on the supporting oral structures. * After confirmation of proper guide fit and stability, implant osteotomies will be performed through the surgical guide following the manufacturer's prescribed drilling sequence. Subsequently, the implants will be inserted according to the manufacturer's recommended surgical protocol. * Final insertion of crowns will be done after 4-6 months.

Arm 1: control group; Arm 2: test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Adult patients aged 18 years or older. 2) Patients with unilateral or bilateral posterior edentulous spaces (free-end saddle cases) requiring implant therapy.
• \) Patients with adequate bone volume for implant placement as determined by CBCT examination.
• \) Medically fit patients eligible for implant surgery. 5) Patient compliance and positive attitude towards oral hygiene.

You may not qualify if:

• \- 1) Patients younger than 18 years. 2) Patients with systemic conditions that may compromise osseointegration or bone healing (e.g., uncontrolled diabetes mellitus, recent radiotherapy to the jaws, severe osteoporosis, history of bisphosphonate therapy).
• \) Pregnant women. 4) noncompliance Patients or patients with poor oral hygiene.

Sponsors & Collaborators

• Mariam Morcos Nasr: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: resident at oral medicine, periodontology, oral diagnosis and radiology departement at Faculty of dentistry - Tanta university

Study Record Dates

• First Submitted: October 17, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): October 25, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10