Tooth LossNCT07534514
Digitally Assisted Immediate Implants in Geriatric Patients
An observational study of Tooth Loss, run by Menoufia University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Digitally Assisted Immediate Implant Placement and Immediate Loading
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Digitally Assisted Immediate Implant Placement and Immediate Loading
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitally Assisted Immediate Implant Placement and Immediate LoadingProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Jan 2025
- Primary completion1 Jul 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed El-Sawy, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534514
- Sponsor's protocol ID
- ADMNF-00426
- Status last verified
- Sep 2026
- First submitted
- 9 Apr 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Up on request from the corresponding authors
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitally Assisted Immediate Implant Placement and Loading in Geriatric Patients
- ClinicalTrials.gov ID
- NCT07534514
- Acronym / sponsor ID
- ADMNF-00426
- Conditions
- Tooth Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digitally Assisted Immediate Implant Placement and Immediate LoadingDigitally 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. | Procedure or surgery | – |
Primary outcome
Implant Survival Rate
Time frame: 12 months
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.
1 secondary outcome
Marginal Bone Level (MBL) Changes
Time frame: Baseline, 6 months, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. Up on request from the corresponding authors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Loss, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Survival Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.