Digitally Assisted Immediate Implants in Geriatric Patients
ConditionTooth Loss
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-80
SponsorMenoufia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus)
History of head and neck radiotherapy
Active untreated periodontal disease
Heavy smoking (>10 cigarettes/day)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Digitally Assisted Immediate Implant Placement and Immediate Loading
Procedure/SurgeryDigitally 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.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
12 monthsSecondary 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.
Time frame
Baseline, 6 months, and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov