PEEK Versus PFM Implant Supported Superstructure

PEEK Implant Supported Restoration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03578913
• Other study ID #: CEBD-CU-2018-06-32
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: July 2018
• Source: Cairo University
• Contact: Reem gabr, master degree
• Phone: 201207158127
• Email: reem_laminate7[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: February 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• PEEK Implant Supported Restoration

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (8)

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. — View 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. Review. — View Citation

Mombelli A, Marxer M, Gaberthüel 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. — View Citation

Parmigiani-Izquierdo JM, Cabaña-Muñoz ME, Merino JJ, Sánchez-Pérez 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. — View 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. — View Citation

UPDEGRAVE WJ. The paralleling extension-cone technique in intraoral dental radiography. Oral Surg Oral Med Oral Pathol. 1951 Oct;4(10):1250-61. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scales (VAS) for measuring the patient satisfaction	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	Crestal bone loss	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
Secondary	Gingival index	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
Secondary	bleeding index	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
Secondary	Probing depth	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