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

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 Document Date: February 20, 2024 
 
Clinical Trial Protocol 
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: 
o 
Completely edentulous mandibular arch 
o 
Adequate bone quantity and quality for implant placement 
o 
Class I maxilla-mandibular relationship 
o 
Sufficient inter-arch space (≥25 mm) 
o 
Good oral hygiene 
• 
Exclusion Criteria: 
o 
Systemic diseases affecting tissue healing 
o 
History of radiation therapy in head/neck region 
o 
Neurological or psychological disorders affecting oral hygiene 
o 
Parafunctional habits 
o 
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: 
o 
Retention force of mandibular overdenture measured in Newtons using a 
digital force meter at insertion, 6 months, and 1 year 
• 
Secondary Outcomes: 
o 
Marginal bone loss around implants measured via digital periapical X-rays at 
insertion, 6 months, and 1 year 
o 
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