Digitally Assisted Immediate Implants in Geriatric Patients

Digitally Assisted Immediate Implant Placement and Loading in Geriatric Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Tooth Loss
• Intervention / Treatment: Procedure: Digitally Assisted Immediate Implant Placement and Immediate Loading

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Mohammed A. Elsawy, PhD; Phone Number: 00201061314522; Email: mohamed.elsawy@dent.menofia.edu.eg

Study Locations

• Egypt
  • Menoufia
    • Shibīn al Kawm, Menoufia, Egypt, 2266166
      • Recruiting
      • Mohammed Elsawy
      • Contact: Mohammed A. Elsawy, PhD; Phone Number: 00201061314522; Email: mohamed.elsawy@dent.menofia.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study will include geriatric patients aged 65 years and older who require extraction of one or more teeth and are eligible for immediate implant placement and loading. All participants must have sufficient residual alveolar bone volume to achieve primary implant stability, an insertion torque ≥35 Ncm and/or ISQ ≥60, and adequate oral hygiene compliance. Patients must have an ASA physical status of I-III.

Exclusion criteria include uncontrolled systemic diseases, history of head and neck radiotherapy, active untreated periodontal disease, heavy smoking (>10 cigarettes/day), bisphosphonate therapy, and parafunctional habits such as severe bruxism.

The study population is expected to reflect typical geriatric patients presenting for implant-supported dental rehabilitation and will allow assessment of biological, mechanical, and patient-centered outcomes in this age group.

Description

Inclusion Criteria:

• Patients aged ≥65 years
• Indication for tooth extraction with immediate implant placement
• Sufficient residual bone volume to achieve primary implant stability
• Ability to achieve insertion torque ≥35 Ncm and/or implant stability quotient (ISQ) ≥60
• American Society of Anesthesiologists (ASA) physical status I-III
• Adequate oral hygiene and patient compliance

Exclusion Criteria:

• Uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus)
• History of head and neck radiotherapy
• Active untreated periodontal disease
• Heavy smoking (>10 cigarettes/day)
• Current or previous bisphosphonate therapy
• Parafunctional habits (e.g., severe bruxism)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Survival Rate	Implant survival will be assessed based on the absence of implant mobility, pain, infection, or radiographic evidence of peri-implant radiolucency throughout the follow-up period.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal Bone Level (MBL) Changes	Changes in marginal bone levels will be measured using standardized periapical radiographs. Measurements will be taken from the implant shoulder to the first bone-to-implant contact at mesial and distal aspects using calibrated digital software.	Baseline, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: ADMNF-00426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Up on request from the corresponding authors

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No