Digitally Assisted Immediate Implants in Geriatric Patients

NCT07534514 | Recruiting DMC

• 1 other identifier: ADMNF-00426
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tooth Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Marginal Bone Level (MBL) Changes

  Baseline, 6 months, and 12 months

Interventions

Digitally Assisted Immediate Implant Placement and Immediate Loading PROCEDURE

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.

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Mohammed Elsawy

Shibīn al Kawm, Menoufia, 2266166, Egypt

RECRUITING

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Central Study Contacts

Mohammed A. Elsawy, PhD

CONTACT

00201061314522; mohamed.elsawy@dent.menofia.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor and principle investigator

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)