Outcomes of Implant-Supported Equator Overdentures Following Fully Guided Static Implant Surgery: A Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Menoufia University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Implant Survival Rate
Study Overview
Brief Summary
This prospective clinical study evaluated the 3-year performance of mandibular implant-supported overdentures (IODs) placed using a fully guided static computer-assisted implant surgery (CAIS) protocol. Primary outcomes included implant survival, peri-implant soft tissue health, and marginal bone loss. Findings provide evidence for the predictability of digital surgical workflows in removable prosthodontics.
Detailed Description
Edentulism remains a prevalent global health concern that compromises oral function, esthetics, and quality of life. While conventional complete dentures are widely used, their limitations in mandibular stability often reduce patient satisfaction. Implant-supported overdentures (IODs) offer superior retention and function, but their long-term success depends heavily on precise implant placement.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Completely edentulous mandible requiring implant-supported overdenture rehabilitation
- •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
- •Uncontrolled systemic diseases (e.g., diabetes mellitus, osteoporosis)
- •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
Outcomes
Primary Outcomes
Implant Survival Rate
Time Frame: From prosthesis delivery to 36 months post-loading
Defined as the percentage of implants remaining in function without mobility, pain, infection, or need for removal during the study period. Survival will be evaluated clinically at each follow-up visit.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohammed El-Sawy
Dr
Menoufia University