MedTrace Logo

Nylon Clip Wear Assessment in Implant

NCT06909435 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-08

No results posted yet for this study

Summary

This study is aimed to compare the wear of nylon caps and patient satisfaction in two-implant overdentures with metal bar and Peek bar overlays in the premolar area:

This prospective clinical trial will involve 14 edentulous patients who will receive two implants in the premolar area. Patients will be randomly assigned to two groups: Group A will receive metal bar overlays, and Group B will receive Peek bar overlays. The patients will be evaluated at baseline,one month ,6 month and 12 month The following parameters will be evaluated:

1. Wear of nylon cap: The wear of the nylon cap will be evaluated using a digital microscope at each follow-up visit.
2. Patient satisfaction: Patients will be asked to rate their satisfaction with the overdentureResults: Metal group showed significantly higher roughness and volumetric changes than PEEK regarding baseline, after 3 months, after 6 months, and after 9 months. and there was insignificant difference between them after 12 months as P=0.11.Patient satisfaction scores were significantly higher in the PEEK group, particularly in retention, stability, comfort, and speech domains at both six months and one year (p = 0.04). on a visual analogue scale (VAS) at each follow-up visit.

Conditions

  • Dental Implant Overdenture
  • Complete Edentulous Patient

Interventions

OTHER

PEEK dental bar

the master stone cast is scanned with external desktop scanner to produce an STL (Standard Tesellation Language) file for a virtual model using the CAD/CAM software (Medit 500i.). The design of the multiunit abutment and bar (Rhein Bar )was selected from the library of the CAD software. The bar dimensions were selected according to the study bar design . After the data acquisition, the STL file was imported to the CAM part of the CAD/CAM system to mill PEEK bar from biological high-performance polymer (Bio-HPP) (BreCAM. BioHPP, Bredent GmbH \& Co.KG, Senden, Germany) block PEEK type. Multi-unit abutments were screwed to the implants and the PEEK bar was screwed to the abutments .

OTHER

Metal bar attachment

Co-Cr metal bar group, in the master cast , the multiunit abutment were attached to the implant analogues and plastic abutments were adjusted , prepared and then wax pattern coping was customized on each abutment and was connected to a preformed castable bar 2.4mm Height, (Rhein 83) The bar was placed to be away from the anterior ridge by about 2-3 mm for proper hygiene measures. The wax pattern was then sprued and casted into cobalt- chromium alloy.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-08
Primary Completion
2024-01-02
Completion
2025-02-20

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06909435 on ClinicalTrials.gov