PEEK Versus PFM Implant Supported Superstructure
- Conditions
- PEEK Implant Supported Restoration
- Registration Number
- NCT03578913
- Lead Sponsor
- Cairo University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Visual analogue scales (VAS) for measuring the patient satisfaction 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.
- Secondary Outcome Measures
Name Time Method Gingival index 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.bleeding index 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.Crestal bone loss 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
Probing depth 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.