Evaluation of PEEK Versus Titanium Bar Attachments With Implant Assisted Mandibular Complete Overdenture Fabricated by CAD/CAM Technology
Evaluation
1 other identifier
interventional
12
1 country
1
Brief Summary
Evaluation of PEEK versus Titanium Bar Attachments with Implant Assisted Mandibular Complete Overdenture fabricated by CAD/CAM Technology measuring retention of the overdenture and implant evaluation for 6 months and one year
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 30, 2024
CompletedFirst Submitted
Initial submission to the registry
September 7, 2025
CompletedFirst Posted
Study publicly available on registry
December 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
December 3, 2025
February 1, 2025
2.3 years
September 7, 2025
November 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
retention of mandibular overdenture
Retention of the mandibular implant-assisted complete overdenture will be measured using a digital force meter. Measurements will be taken at 6 months and 12 months after denture insertion.
6 months and 12 months post-insertion
Study Arms (4)
Evaluation of PEEK material
EXPERIMENTALdigital fabrications techniques
Group Ӏ (control group): Six patients will receive digital mandibular implant overdenture assisted b
ACTIVE COMPARATOR• Clinical evaluation
PEEK group new material
EXPERIMENTALPEEK material study group
EXPERIMENTALInterventions
using of CAD/CAM with new material and digital fabrication techniques
Eligibility Criteria
You may qualify if:
- Completely edentulous patients free from systemic diseases that may affect soft or hard tissue healing.
- Patient's age ranges from 40 to 60 years old.
- The bone quality and quantity of the mandibular alveolar ridge must fulfill the criteria for implant placement.
- They have normal class Ӏ maxilla-mandibular relationship and sufficient inter-arch space with at least 25mm for bar attachment.
- They have good oral hygiene.
You may not qualify if:
- Systemic disorders that may influence soft or hard tissue healing as oral diseases.
- Patients with history of radiation therapy in the head and neck region.
- Patients with neurological or psychological problems that may impair good oral hygiene.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Faculty of Dentistry
Tanta, Elgharbiy, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
September 7, 2025
First Posted
December 3, 2025
Study Start
May 30, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
December 3, 2025
Record last verified: 2025-02