Clinical trial NCT03578913: PEEK Versus PFM Implant Supported Superstructure
Official title: Assessment of Peri-Implant Tissues Surrounding PEEK and Porcelain Fused to Metal Superstructures in Posterior Region (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PEEK Implant Supported Restoration
Keywords: PFM implant supported restoration
Clinical assessment
radiographic assessment
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient will receive a restoration with superior function, ethetic, and excellent clinical performance.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual analogue scales (VAS) for measuring the patient satisfaction
timeFrame: 12 months
Secondary outcomes:
measure: Crestal bone loss
timeFrame: 12 months
measure: Gingival index
timeFrame: 12 months
measure: bleeding index
timeFrame: 12 months
measure: Probing depth
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Weinberg LA. The biomechanics of force distribution in implant-supported prostheses. Int J Oral Maxillofac Implants. 1993;8(1):19-31.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.