PEEK Versus Metallic Framework for Extra Coronal Attachment

NCT04990453 | Completed DMC

• 1 other identifier: KD/12/21
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: The present study was aimed to evaluate the bone height changes around abutments with two different framework materials for extracoronal attachment mandibular bilateral distally extension removable partial denture (RPD) and compare patient satisfaction associated with its use. Materials and methods: Ten partially edentulous patients (long span kennedy class I) were selected, for all patients splinting of remaining abutment were done by porcelain fused to metal bridges, after cementation the RPD frameworks were digitally designed by CAD software and printed into 3-D resin pattern after intra-oral try in of these patterns, the patients were divided into two equalized groups, the patients in first group received extracoronal attachment (RPD)with from milled PEEK (Juvora) framework. While patients in second group received extracoronal attachment (RPD) with conventional metal framework by lost wax technique. Digital radiography was used for bone height assessment of distal abutment at time of prosthesis insertion, 6 and 12 months later. Patient satisfaction was measured using VAS scale.

Conditions

Removable Partial Denture

Keywords

Framework materials; Removable partial denture; Patient satisfaction; PEEK; Bone changes

Outcome Measures

Primary Outcomes (1)

• evaluation of bone height changes

  An image plate was attached on a radiographic stent specially constructed for each patient to made a standardized periapical radiograph for the abutments by using the Dentsply/rinn XCP tools (long, round BID cone paralleling technique) according to: Image analysis: The linear measurement system contributed by the special software of the Vista-scan machine was used for measuring the mesial and distal marginal bone height around the canine abutments bilaterally in both groups.

  12 months

Secondary Outcomes (1)

• Patient satisfaction (VAS)

  12 months

Study Arms (2)

RPD frameworks fabricated from PEEK material

OTHER

14 patients received extracoronal precision attachment RPD frameworks fabricated from PEEK material using milling machine (CAD/CAM technology)

Other: RPD frameworks fabricated from PEEK material

RPD frameworks fabricated from Co-Cr

OTHER

14 patients received extracoronal precision attachment RPD frameworks fabricated from Co-Cr material using casting machine

Other: RPD frameworks fabricated from PEEK material

Interventions

RPD frameworks fabricated from PEEK material OTHER

extracoronal precision attachment RPD frameworks fabricated from PEEK material using milling machine (CAD/CAM technology)

RPD frameworks fabricated from Co-Cr; RPD frameworks fabricated from PEEK material

Eligibility Criteria

• Age: 55 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The average age of selected patients was from 55 -60 years .
• Completely edentulous maxillary arch opposed by partially edentulous mandible with only remaining mandibular anterior teeth.
• All selected patients were free from any systemic diseases,
• All patients had Angle class I maxillomandibular skeletal relation,
• The distal extension ridge was well formed and covered by healthful, firm mucosa,
• Suitable abutments with healthy periodontal ligament and appropriate crown/root ratio (CRR) as verified by periapical radiograph.

You may not qualify if:

• patients with any systemic disease that could affect the rate of bone resorption which confirmed by obtaining a medical history,
• Patients with Para-functional habits (Bruxism and clenching),
• Patients with any septic foci or impacted teeth as proved by panoramic radiograph,
• Patients with tilted or rotated abutments. Patients with soft tissue undercuts had involved in the design.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Faculty of Oral & Dental Medicine,Kafr El-shiekh University, Kafr El-shiekh ,Egypt

Kafr El-shiekh, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer , Prosthodontist, Department of Prosthodontics, Faculty of Oral & Dental Medicine,Kafr El-shiekh University, Kafr El-shiekh ,Egypt.

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 4, 2021
• Study Start: February 2, 2020
• Primary Completion: April 15, 2021
• Study Completion: May 15, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)