Prospective Outcomes of Guided Equator Overdentures

NCT07196943 | Recruiting

• 1 other identifier: ADMNF-011225
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bone Loss

Outcome Measures

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.

  From prosthesis delivery to 36 months post-loading

Interventions

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.

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Menoufia University: lead
• Mansoura University: collaborator

Study Sites (1)

Faculty of Dentistry

Shibīn al Kawm, Egypt

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mohammed El-Sawy, PhD

  Menoufia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed A. El-Sawy, PhD

CONTACT

00201061314522; Dr_sawy@windowslive.com

Mohammed T. Khater, PhD

CONTACT

00201003854552; MohamedKhaterdentalsmile1234@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 20, 2025
• First Posted: September 29, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)