Nylon Clip Wear Assessment in Implant

NCT06909435 | Completed DMC

• 1 other identifier: esthetic committee 49-7-32
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 1.Wear of nylon cap: The wear of the nylon cap will be evaluated using a digital microscope at each follow-up visit.
2. 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

Keywords

implant; bar attachment; nylon clip; wear; overdenture

Outcome Measures

Primary Outcomes (1)

• attachment clip wear

  Plastic clip wear and roughness were analyzed on overdenture insertion and after 3,6,9 month and 1 year of clinical usage in a 3D-surface analyzer system.27Fitting surface of denture with the nylon clip were photographed using USB Digital microscope with a built-in camera (Scope Capture Digital Microscope, Guangdong, China) connected with an IBM compatible personal computer using a fixed magnification of 120X.The images were recorded with a resolution of 1280 × 1024 pixels per image. Digital microscope images were cropped to 350 x 400 pixels using Microsoft office picture manager to standardize area of roughness measurement. WSxM software used for measure the average of heights of volumetric changes and surface roughness which expressed in μm, 28 a 3D image of the surface plastic clip was created ready for a 3-dimensional geometric analysis by the using a digital image analysis system (Image J 1.43U, National Institute of Health, USA). The intact unworn surface used as a reference.

  base line ,3,6 and12 month

Secondary Outcomes (1)

• patient satisfaction

  base line ,3,6 and12 month

Study Arms (2)

PEEK bar

SHAM COMPARATOR

Peek bar attachment with Nylon clip for retaining overdenture

Other: PEEK dental bar

Metal bar

SHAM COMPARATOR

metal bar attachment to retain implant overdenture

Other: Metal bar attachment

Interventions

PEEK dental bar OTHER

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 .

PEEK bar

Metal bar attachment OTHER

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.

Metal bar

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- good bone quantity and quality especially in the anterior interforaminal region as detected by CBCT and sufficient inter-arch space, minimally 12-14 mm from the ridge to the occlusal plane

You may not qualify if:

• diabetic patient or patient received radiation therapy, or with parafunctional habits, and smokers should be excluded from the study

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Faculty of dentistry

Cairo, Cairo Governorate, 1211, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor ,Cairo university ,Faculty of dentistry

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: April 8, 2023
• Primary Completion: January 2, 2024
• Study Completion: February 20, 2025
• Last Updated: April 8, 2025

Record last verified: 2023-01

Locations

EG (1)