Prospective Outcomes of Guided Equator Overdentures

Recruiting

• Conditions: Bone Loss

• Registration Number: NCT07196943
• Lead Sponsor: Menoufia University

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.

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.

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-20
• Study First Submitted QC: 2025-09-20
• Last Update Submitted: 2025-09-20
• Study First Posted: 2025-09-29
• Last Update Posted: 2025-09-29
• Primary Completion: 2028-12-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant Survival Rate	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.

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Shibīn al Kawm, Egypt