PEEK Versus PFM Implant Supported Superstructure

July 6, 2018 updated by: Reem Mohamed Ali Gabr, Cairo University

Assessment of Peri-Implant Tissues Surrounding PEEK and Porcelain Fused to Metal Superstructures in Posterior Region (Randomized Controlled Clinical Trial)

The purpose of this study is to evaluate the influence of two superstructure materials Porcelain Fused to Metal (PFM) and PEEK on peri- implant soft and hard tissue reaction clinically.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Nowadays the use of dental implants for restoring missing teeth has gained a wide acceptance, due to its high success rate.

Dental implants differ from natural teeth in transmission of functional loads to the bone, where natural teeth and their periodontal ligaments provide proprioception, early detection of occlusal loads and have a shock-absorbing function. Sensitivity and mobility of natural teeth cannot be duplicated in osseointegrated implants,1 therefore most of the forces are concentrated at the crest of the ridge leading to different living reaction including bone resorption and subsequent implant loss.

Minimizing the occlusal loads on osseointegrated implants through selection of a new superstructure material that can absorb part of this excessive force could be believed to be a determining factor in the long-term success of an implant treatment program.

Many restorative materials are used nowadays for construction of final restoration of implant supported superstructures including porcelain fused to metal (PFM), all ceramic, zirconia, hybrid ceramics, and polyetheretherketone (PEEK). PFM restorations are still considered as the gold standard because of their excellent biocompatibility, consistent esthetics, superior strength, and marginal adaptation. Recently, the use of new resilient superstructure material like PEEK-based restoration on implant prosthetics could modify the occlusal forces with subsequent cushioning during function.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients above 18 years old.
  • Patients able to read and sign the informed consent document.
  • Medically free patients or with controlled systemic disease.
  • Patients with good bone quality and quantity.
  • Patients willing to return for follow-up examinations and evaluation.
  • Patients having single successfully osseointegrated implant in posterior region.

Exclusion criteria

  • Young patients in growth stage.
  • Patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption)
  • Pregnant women to avoid any complication that may occur in dental office.
  • Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient)
  • Psychiatric problems or unrealistic expectations.
  • Multiple adjacent missing teeth.
  • Patients with bad oral hygiene.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: porcelain fused to metal crown
Although metal free restorations are gained popularity recently, PFM restorations, whether they are tooth-supported or implant-supported are still considered as the gold standard due to their excellent biocompatibility, consistent esthetics, superior strength, and marginal adaptation.2 PFM restorations are also considered durable and long-lasting
Other: PEEK crown
The main concern of dental implants is their lack of elasticity, therefore with the use of PFM, all ceramic or zirconia crowns; the load is directly transferred to bone. That is why up till now researchers are in quest of different materials to enhance soft and hard tissue reaction around implant supported restorations. Recently the use of PEEK as a final restoration on dental implants has wide acceptance, due to its excellent biocompatibility and exceptional physical and chemical properties regarding toughness, hardness and elasticity. In term of load cushioning capacity of the prosthetic elements, PEEK has a comparable modulus of elasticity (4GPa) to that of bone (4.2GPa). Thus, the bone could allow bone stimulation favoring its remodeling without overloading.
Other Names:
  • polyetherether ketone
Other: PFM Crown
Although metal free restorations are gained popularity recently, PFM restorations, whether they are tooth-supported or implant-supported are still considered as the gold standard due to their excellent biocompatibility, consistent esthetics, superior strength, and marginal adaptation.2 PFM restorations are also considered durable and long-lasting
Other Names:
  • metal ceramic restoration
Experimental: PEEK crown
The main concern of dental implants is their lack of elasticity, therefore with the use of PFM, all ceramic or zirconia crowns; the load is directly transferred to bone. That is why up till now researchers are in quest of different materials to enhance soft and hard tissue reaction around implant supported restorations. Recently the use of PEEK as a final restoration on dental implants has wide acceptance, due to its excellent biocompatibility and exceptional physical and chemical properties regarding toughness, hardness and elasticity. In term of load cushioning capacity of the prosthetic elements, PEEK has a comparable modulus of elasticity (4GPa) to that of bone (4.2GPa). Thus, the bone could allow bone stimulation favoring its remodeling without overloading
Other: PEEK crown
The main concern of dental implants is their lack of elasticity, therefore with the use of PFM, all ceramic or zirconia crowns; the load is directly transferred to bone. That is why up till now researchers are in quest of different materials to enhance soft and hard tissue reaction around implant supported restorations. Recently the use of PEEK as a final restoration on dental implants has wide acceptance, due to its excellent biocompatibility and exceptional physical and chemical properties regarding toughness, hardness and elasticity. In term of load cushioning capacity of the prosthetic elements, PEEK has a comparable modulus of elasticity (4GPa) to that of bone (4.2GPa). Thus, the bone could allow bone stimulation favoring its remodeling without overloading.
Other Names:
  • polyetherether ketone
Other: PFM Crown
Although metal free restorations are gained popularity recently, PFM restorations, whether they are tooth-supported or implant-supported are still considered as the gold standard due to their excellent biocompatibility, consistent esthetics, superior strength, and marginal adaptation.2 PFM restorations are also considered durable and long-lasting
Other Names:
  • metal ceramic restoration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scales (VAS) for measuring the patient satisfaction
Time Frame: 12 months
Visual analogue scales will be used before the treatment and at the follow-ups to record and evaluate subjective patient's perceptions including the appraisal of function eating, esthetics, sense, speech, and self-esteem. The patients were asked to mark their subjective perception in each category on a horizontal line (100 mm in length), 1 mm (the minimum score) corresponded to 1% of satisfaction and 100 mm (the maximum score) corresponded to 100% of satisfaction.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Crestal bone loss
Time Frame: 12 months
Intraoral X-rays will be made using the long-cone parallel technique for the two groups. All radiographs were digitized for evaluation of the bone levels (BL) at different time points. The marginal BL was determined by measuring the distance between the implant shoulder (reference) and the most coronal bone-to implant contact. These measurements were made by two independent examiners mesially and distally of the implants and in 0.1-mm increments
12 months
Gingival index
Time Frame: 12 months

Gingival index of the two groups will be assessed by the Loe & Silness gingival index as follow:

  • Grade 0: (Normal gingival) Natural coral pink gingival.
  • Grade 1: (Mild inflammation) Slight change in color, slight edema. No bleeding on probing.
  • Grade 2: (Moderate inflammation) Redness, edema and glazing. Bleeding on probing.
  • Grade 3: (Severe inflammation) Marked redness and edema. Tendency to spontaneous bleeding. Ulceration.
12 months
bleeding index
Time Frame: 12 months

Bleeding index of the two groups will be assessed by Modified sulcus bleeding index11 With a periodontal probe (PCB 12; Hu-Friedy, Leimen, Germany) inserted about 1mm into the peri-implant epithelium, the sulcus was scratched over its facial and oral surface as follow:

  • Grade 0: No bleeding.
  • Grade 1: Isolated points of bleeding.
  • Grade 2: The blood forms a confluence line at the epithelium.
  • Grade 3: Massive bleeding/spontaneous bleeding.
12 months
Probing depth
Time Frame: 12 months

Probing pocket depth (PPD) for the two groups will be measured from the mucosal margin to the bottom of the probeable pocket in millimeters with a periodontal probe (PCB 12; Hu-Friedy, Leimen, Germany) at four aspects per implant

  • mesial
  • distal
  • buccal
  • lingual The subscales will be summed and an average will be taken.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

June 24, 2018

First Submitted That Met QC Criteria

July 5, 2018

First Posted (Actual)

July 6, 2018

Study Record Updates

Last Update Posted (Actual)

July 9, 2018

Last Update Submitted That Met QC Criteria

July 6, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CEBD-CU-2018-06-32

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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