Evaluation of PEEK Versus Titanium Bar Attachments With Implant Assisted Mandibular Complete Overdenture Fabricated by CAD/CAM Technology
Phase: NA
Conditions: Edentulism in Lower Jaw
Sponsor: Tanta University

Clinical Trial Protocol 
 
Brief Title: 
Evaluation of PEEK Versus Titanium Bar Attachments with Implant-Assisted Mandibular 
Complete Overdenture Fabricated by CAD/CAM Technology 
 
Official Title: 
Evaluation of PEEK Versus Titanium Bar Attachments with Implant-Assisted Mandibular 
Complete Overdenture Fabricated by CAD/CAM Technology 
 
NCT Number: 
Not yet assigned 
 
Study Type: 
Interventional (Clinical Trial) 
 
Study Design: 
- Allocation: Randomized 
- Intervention Model: Parallel Assignment 
- Masking: None (Open Label) 
- Primary Purpose: Treatment 
 
Study Population: 
- Total Sample Size: 12 patients 
- Age Range: 40–60 years 
- Inclusion Criteria: 
  - Completely edentulous mandibular arch 
  - Adequate bone quantity and quality for implant placement 
  - Class I maxilla-mandibular relationship 
  - Sufficient inter-arch space (≥25 mm) 
  - Good oral hygiene 
- Exclusion Criteria: 
  - Systemic diseases affecting tissue healing 
  - History of radiation therapy in head/neck region 
  - Neurological or psychological disorders affecting oral hygiene 
  - Parafunctional habits 
  - Heavy smoking, alcoholism, or drug abuse 
 
Study Groups / Interventions: 
- Group I (Control): CAD/CAM Titanium bar attachment mandibular overdenture (6 
patients) 

- Group II (Study): CAD/CAM PEEK bar attachment mandibular overdenture (6 patients) 
 
Outcome Measures: 
Primary Outcome: 
- Retention force of mandibular overdenture measured in Newtons using a digital force 
meter at insertion, 6 months, and 1 year 
 
Secondary Outcomes: 
- Marginal bone loss around implants measured via digital periapical X-rays at insertion, 6 
months, and 1 year 
- Bar deviation assessed digitally by STL file superimposition at 6 months and 1 year 
 
Study Setting: 
Prosthodontics Department, Faculty of Dentistry, Tanta University, and CAD/CAM 
laboratory 
 
Ethical Consideration: 
Informed consent will be obtained from all participants according to the guidelines of the 
Research Ethics Committee, Faculty of Dentistry, Tanta University 
 
Key References (Optional): 
1. Resnik RR. Misch’s Contemporary Implant Dentistry. 4th ed. Elsevier; 2020. 
2. Abdullah A, Muhammed F, Zheng B, Liu Y. An Overview of CAD/CAM in Restorative 
Dentistry. Dent Mater J. 2018;7:1-10. 
3. Elkady DM, El-Sherbini NN. Footprint of Different Bar Materials on Complete Overdenture 
Retention. ADJC. 2023;5:397-404.