Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2025-09-01
2028-12-01
Brief Summary
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Detailed Description
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Computer-assisted implant surgery (CAIS), particularly static fully guided protocols, has been shown to enhance surgical accuracy in fixed prosthodontics. However, evidence for their application in removable prosthodontics remains limited, despite the anatomical and prosthetic challenges often encountered in overdenture cases.
This prospective clinical study was designed to assess the 3-year clinical performance of mandibular IODs placed via a fully guided static CAIS workflow. Outcomes included implant survival, peri-implant soft tissue health, and marginal bone changes. The results provide valuable clinical insight into the role of digital surgical protocols in improving predictability and long-term success of overdenture rehabilitation.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Fully guided static computer-assisted implant surgery (CAIS) for mandibular overdentures using Equator® attachments
Mandibular edentulism will be rehabilitated with implant-supported overdentures using a fully guided static computer-assisted implant surgery (CAIS) protocol. Each patient will receive four implants placed in a quadrilateral configuration (lateral incisor and first premolar regions) under a stereolithographically manufactured surgical guide. Following 3-4 months of osseointegration, definitive mandibular overdentures will be fabricated and retained exclusively with Equator® attachment systems (Rhein 83, Bologna, Italy). Patients will be followed for 3 years to assess implant survival, peri-implant soft tissue health, and marginal bone changes.
Eligibility Criteria
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Inclusion Criteria
* Adequate bone volume to accommodate four implants in a quadrilateral configuration, confirmed by cone-beam computed tomography (CBCT)
* Age between 40 and 75 years
* Good general health with no systemic contraindications to implant surgery
* Willingness and ability to provide informed consent
* Commitment to attend all scheduled follow-up visits over the 3-year study period
Exclusion Criteria
* History of radiotherapy in the head and neck region
* Untreated oral infections or severe periodontal disease
* Poor oral hygiene or inability to comply with maintenance protocols
* Heavy smoking (\>10 cigarettes/day) or alcohol abuse
* Known allergy or intolerance to materials or medications used in the study
40 Years
70 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Menoufia University
OTHER
Responsible Party
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Mohammed El-Sawy
Dr
Principal Investigators
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Mohammed El-Sawy, PhD
Role: PRINCIPAL_INVESTIGATOR
Menoufia University
Locations
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Faculty of Dentistry
Shibīn al Kawm, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ADMNF-011225
Identifier Type: -
Identifier Source: org_study_id
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