PEEK Versus PFM Implant Supported Superstructure

NCT ID: NCT03578913

Last Updated: 2018-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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PEEK Implant Supported Restoration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patient will receive a restoration with superior function, ethetic, and excellent clinical performance.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Double blind (Patients and outcome assessors) both patient and assessor will be blinded to the assigned material. However the operator can't be blinded due to the difference in preparation and shade of the ceramic materials. Reem Gabr will be responsible for the try-in and final delivery of the crowns.

-The assessor will assess all outcomes blinded to the material assigned for each patient.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

PEEK crown

Intervention Type OTHER

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.

PFM Crown

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

PEEK crown

Intervention Type OTHER

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.

PFM Crown

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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polyetherether ketone metal ceramic restoration

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Reem Mohamed Ali Gabr

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Reem gabr, master degree

Role: CONTACT

201207158127

rana sherif

Role: CONTACT

201001416985

References

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Weinberg LA. The biomechanics of force distribution in implant-supported prostheses. Int J Oral Maxillofac Implants. 1993;8(1):19-31.

Reference Type BACKGROUND
PMID: 8468083 (View on PubMed)

Walton TR. An up to 15-year longitudinal study of 515 metal-ceramic FPDs: Part 1. Outcome. Int J Prosthodont. 2002 Sep-Oct;15(5):439-45.

Reference Type BACKGROUND
PMID: 12375457 (View on PubMed)

Ponnappan RK, Serhan H, Zarda B, Patel R, Albert T, Vaccaro AR. Biomechanical evaluation and comparison of polyetheretherketone rod system to traditional titanium rod fixation. Spine J. 2009 Mar;9(3):263-7. doi: 10.1016/j.spinee.2008.08.002. Epub 2008 Oct 1.

Reference Type BACKGROUND
PMID: 18838341 (View on PubMed)

Han KH, Lee JY, Shin SW. Implant- and Tooth-Supported Fixed Prostheses Using a High-Performance Polymer (Pekkton) Framework. Int J Prosthodont. 2016 Sep-Oct;29(5):451-4. doi: 10.11607/ijp.4688.

Reference Type BACKGROUND
PMID: 27611747 (View on PubMed)

Parmigiani-Izquierdo JM, Cabana-Munoz ME, Merino JJ, Sanchez-Perez A. Zirconia implants and peek restorations for the replacement of upper molars. Int J Implant Dent. 2017 Dec;3(1):5. doi: 10.1186/s40729-016-0062-2. Epub 2017 Feb 20.

Reference Type BACKGROUND
PMID: 28220366 (View on PubMed)

Mombelli A, Marxer M, Gaberthuel T, Grunder U, Lang NP. The microbiota of osseointegrated implants in patients with a history of periodontal disease. J Clin Periodontol. 1995 Feb;22(2):124-30. doi: 10.1111/j.1600-051x.1995.tb00123.x.

Reference Type BACKGROUND
PMID: 7775668 (View on PubMed)

Landry RG, Jean M. Periodontal Screening and Recording (PSR) Index: precursors, utility and limitations in a clinical setting. Int Dent J. 2002 Feb;52(1):35-40. doi: 10.1111/j.1875-595x.2002.tb00595.x.

Reference Type BACKGROUND
PMID: 11931220 (View on PubMed)

UPDEGRAVE WJ. The paralleling extension-cone technique in intraoral dental radiography. Oral Surg Oral Med Oral Pathol. 1951 Oct;4(10):1250-61. doi: 10.1016/0030-4220(51)90084-9. No abstract available.

Reference Type BACKGROUND
PMID: 14882798 (View on PubMed)

Other Identifiers

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CEBD-CU-2018-06-32

Identifier Type: -

Identifier Source: org_study_id

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