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Prospective Outcomes of Guided Equator Overdentures

M

Menoufia University

Status

Enrolling

Conditions

Bone Loss

Treatments

Device: Fully guided static computer-assisted implant surgery (CAIS) for mandibular overdentures using Equator® attachments

Study type

Observational

Funder types

Other

Identifiers

NCT07196943
ADMNF-011225

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  • 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

Trial contacts and locations

1

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Central trial contact

Mohammed A. El-Sawy, PhD; Mohammed T. Khater, PhD

Data sourced from clinicaltrials.gov

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