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Recruiting NCT07196943

Prospective Outcomes of Guided Equator Overdentures

Observational Bone Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fully guided static computer-assisted implant surgery (CAIS) for mandibular overdentures using Equator® attachments.
Who it may be relevant to
Registry conditions: Bone Loss. Basic parameters: 40 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Device 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 (R

Primary outcome measures

  • Implant Survival Rate [Time frame: From prosthesis delivery to 36 months post-loading]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Faculty of Dentistry — Shibīn al Kawm

Identifiers

NCT: NCT07196943 · ADMNF-011225

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗