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NCT Number: NCT07196943

Prospective Outcomes of Guided Equator Overdentures

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

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

Device

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed A. El-Sawy, PhD

CONTACT

[email protected]

00201061314522

Mohammed T. Khater, PhD

CONTACT

[email protected]

00201003854552

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Collaborators

  • Mansoura University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 29, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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