RecruitingNCT07196943

Prospective Outcomes of Guided Equator Overdentures

Outcomes of Implant-Supported Equator Overdentures Following Fully Guided Static Implant Surgery: A Prospective Study


Sponsor

Menoufia University

Enrollment

40 participants

Start Date

Sep 1, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 70 Years

Inclusion Criteria6

  • 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 Criteria6

  • 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

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Interventions

DEVICEFully 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.


Locations(1)

Faculty of Dentistry

Shibīn al Kawm, Egypt

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NCT07196943


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