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

Study Protocol
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
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
References: 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.
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