Prospective Outcomes of Guided Equator Overdentures
ConditionBone Loss
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-70
SponsorMenoufia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population consists of completely edentulous adults aged 40-70 years, recruited from the outpatient clinic of \[Institution Name\]. All participants require mandibular implant-supported overdenture rehabilitation and have adequate bone volume to accommodate four implants in a quadrilateral configuration. Patients must be in good general health, able to provide informed consent, and committed to attending scheduled follow-up visits over the 3-year study period.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Fully guided static computer-assisted implant surgery (CAIS) for mandibular overdentures using Equator® attachments
DeviceMandibular 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Implant Survival Rate
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.
Time frame
From prosthesis delivery to 36 months post-loadingSponsors and contacts
Click on the lead sponsor to view all of their trials.
Menoufia University
Lead sponsor
Mansoura University
Collaborator
Source ClinicalTrials.gov