NCT07534514

Digitally Assisted Immediate Implants in Geriatric Patients

Digitally Assisted Immediate Implant Placement and Loading in Geriatric Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Menoufia University · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: —

Summary

This prospective clinical study aims to evaluate the clinical performance of digitally assisted immediate implant placement and immediate loading in geriatric patients. The study will assess biological outcomes, including implant survival and marginal bone level changes, as well as mechanical complications and primary stability progression. Additionally, patient-reported outcomes such as pain, functional improvement, and esthetic satisfaction will be evaluated using visual analog scales. A fully digital workflow incorporating CBCT, intraoral scanning, and guided surgery will be utilized to enhance treatment accuracy and efficiency. Patients will be followed for 12 months to determine the predictability and effectiveness of this treatment approach in the elderly population.

Detailed description

Detailed Description The increasing life expectancy worldwide has resulted in a growing geriatric population with complex dental rehabilitation needs. Elderly patients frequently present with partial edentulism, reduced bone quality, systemic comorbidities, and functional limitations that may complicate conventional implant therapy. Therefore, treatment approaches that minimize surgical interventions, reduce overall treatment time, and enhance functional recovery are of particular importance in this population. Immediate implant placement following tooth extraction has been advocated as a strategy to preserve alveolar bone architecture and reduce the number of surgical procedures. When combined with immediate loading protocols, this approach may further improve patient comfort, shorten edentulous periods, and accelerate functional and esthetic rehabilitation. However, concerns remain regarding primary implant stability, marginal bone preservation, and the risk of biological and mechanical complications-especially in geriatric patients who may exhibit decreased bone density and altered healing capacity. Primary stability is a critical determinant for the success of immediate loading protocols and is commonly assessed using insertion torque and resonance frequency analysis (implant stability quotient, ISQ). Achieving adequate primary stability is essential to minimize micromovement and facilitate successful osseointegration. While favorable outcomes have been reported in general populations, evidence focusing specifically on elderly patients undergoing immediate implant placement and loading remains limited. The integration of digital technologies has significantly advanced implant dentistry. The use of cone beam computed tomography (CBCT), intraoral optical scanning, and computer-assisted implant planning enables prosthetically driven implant positioning with improved accuracy and predictability. Additionally, static guided surgery may reduce surgical time, enhance precision, and limit intraoperative trauma, which is particularly advantageous in medically compromised or elderly individuals. Despite these potential benefits, comprehensive prospective data evaluating the combined effect of digital workflows and immediate loading protocols in geriatric patients are still lacking. This prospective clinical study is designed to evaluate the clinical performance and predictability of a fully digital workflow for immediate implant placement and loading in patients aged 65 years and older. The digital workflow includes CBCT-based three-dimensional assessment, intraoral scanning, merging of DICOM and STL datasets, virtual implant planning, and fabrication of CAD/CAM-generated, tooth-supported surgical guides to facilitate prosthetically driven implant placement. All surgical procedures will be performed using a minimally invasive approach, with flapless or minimally reflected techniques whenever feasible, followed by guided implant placement. Primary stability will be assessed at the time of implant insertion using insertion torque measurements and ISQ values. Immediate provisional restorations will be delivered within 48 hours, with occlusal adjustments made to control loading conditions based on implant stability. Patients will be followed for a period of 12 months with scheduled clinical and radiographic evaluations. The primary outcomes include implant survival rate and marginal bone level changes assessed using standardized periapical radiographs. Secondary outcomes include biological complications (such as peri-implant mucositis and peri-implantitis), prosthetic complications (including screw loosening and prosthesis fracture), and patient-reported outcome measures (PROMs) evaluated using visual analog scales for pain, esthetics, function, and overall satisfaction. The findings of this study are expected to provide clinically relevant evidence regarding the safety, efficiency, and predictability of digitally assisted immediate implant placement and loading in geriatric patients. This may contribute to optimizing treatment protocols and improving quality of care for the aging population.

Conditions

• Tooth Loss

Interventions

Type	Name	Description
PROCEDURE	Digitally Assisted Immediate Implant Placement and Immediate Loading	Digitally assisted immediate implant placement and loading will be performed in geriatric patients requiring tooth extraction. A fully digital workflow including CBCT and intraoral scanning will guide prosthetically driven implant placement using a CAD/CAM-fabricated tooth-supported surgical guide. Primary stability will be assessed using insertion torque and ISQ. Immediate screw-retained provisional restorations will be delivered within 48 hours, with occlusion adjusted to control loading. Minor peri-implant gaps will be grafted as needed. Definitive prostheses will be delivered after 3-6 months, and patients will be followed clinically and radiographically for 12 months to assess biological, mechanical, and patient-centered outcomes.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-07-01
• Completion: 2026-10-01
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: Egypt