PEEK Versus Titanium Customized Healing Abutments

Study Overview
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Brief Summary
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The study suggests that if the investigators used customized healing abutments synthesized from PEEK may have a favorable effect on peri-implant soft tissues regarding decreased plaque accumulation and healing stimulation compared to the customized conventional titanium healing abutments.

Detailed Description
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Successful aesthetic implant therapy has several sequential goals such as prosthetically driven 3D implant placement. Implant placement must be done in the ideal position to support the restoration and the surrounding soft and hard tissues. The placement of a definitive restoration should also be in harmony with the adjacent natural teeth and surrounding soft tissue. Guided implant surgery can provide precise, predictable, and safe implant placement. Computer-generated surgical guides vary in design according to the dental condition (edentulous or partially edentulous), type of support (tooth, mucosa, or bone), and the degree of limitation (non-limiting, partially-limiting, or completely limiting). The use of healing abutments has the function which enables adequate healing of peri-implant soft tissue and promoting a good profile of peri-implant mucosa that allows an adequate emergence profile of the prostheses supported by the implant. They are available in different lengths and project through the soft tissue into the oral cavity. Janakievski stated that prefabricated healing abutments are unable to support the supracrestal soft tissues because of their circular profile. Therefore, a custom healing abutment is preferred because it provides a replica of the definitive restoration of the patient's gingival architecture. An evaluation of the use of customized healing abutments has been performed aiming to assess possible advantages associated with this treatment modality. This procedure allows to maintain the peri-implant tissue and improve aesthetics until crown delivery. CAD/CAM enables the fabrication of high-quality implant abutments from solid blocks of different materials. The contours of the healing abutment are based on the contours of a provisionally designed definitive prosthesis. The healing abutment promotes tissue healing and obtains contours that are well-matched with the contours of the definitive prosthesis. Currently healing abutments made of polymers such as polyetheretherketone (PEEK) which have been used in orthopedic surgery, are used in dentistry, because of aesthetic & biological reasons maintaining the health of peri-implant soft tissues during healing. Polyetheretherketone (PEEK) healing abutments can be chosen instead of titanium healing abutments because of their superior properties such as biocompatibility, inert chemical properties, white color, and decreased liability for biofilm accumulation. Research Question May PEEK healing abutment have a favorable effect on peri-implant soft tissue that may be related to the superior biological properties of PEEK regarding both decreased biofilm accumulation& healing stimulation?

Official Title
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PEEK Versus Titanium Customized Healing Abutments: Evaluation of Peri-implant Soft Tissues and Sulcus Fluid Bacterial Load

Conditions
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Dental Implants

Intervention / Treatment
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* Device: PEEK customized healing abutment
* Device: Titanium customized healing abutment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients should be systematically free from any disease as according to Cornell Medical Index-Health Questionnaire . Both genders. Age from 20-50 years. Missing tooth in esthetic zone (Anterior/Premolar) to be restored with standard implant, with no need for additional bone and soft tissue augmentation procedures. Implants primary stability ISQ ≥ 70 unites using the Osstell Mentor BuccoLingual bone width ≥ 6 mm. Mesio distal space ≥ 7 mm Sound Mesial and distal neighboring teeth. At least 6 natural teeth remaining in the same arch . Mouth opening ≥ 30mm. Enough keratinized mucosa. Thick phenotype. Exclusion Criteria: Poor oral hygiene condition. Pregnant and lactating females. Smokers.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEEK customized healing abutment.<br>Group I (Customized PEEK Healing Abutment): 13 patients will receive guided delayed implant and a customized PEEK healing abutment placed simultaneously with implant surgery | Device: PEEK customized healing abutment<br>* Guided delayed implant and a customized PEEK healing abutment placed simultaneously with implant surgery<br>|
| Active Comparator: Titanium customized healing abutment.<br>Group II (Customized Titanium Healing Abutment): 13 patients will receive guided delayed implant and a customized titanium healing abutment placed simultaneously with implant surgery. | Device: Titanium customized healing abutment<br>* Guided delayed implant and a customized Titanium healing abutment placed simultaneously with implant surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation of peri-implant soft tissue changes | Clinical evaluation of peri-implant soft tissue changes the Probing Depth (PD). | 1 month after implantation and 4 months after implantation (just before prosthetic procedures) | 
| Clinical evaluation of peri-implant soft tissue changes | Clinical evaluation of peri-implant soft tissue changes the Plaque Index (PI) score. | 1 month after implantation and 4 months after implantation (just before prosthetic procedures) | 
| Clinical evaluation of peri-implant soft tissue changes | Clinical evaluation of peri-implant soft tissue changes the Gingival Index (GI)score. | 1 month after implantation and 4 months after implantation (just before prosthetic procedures) | 
| Clinical evaluation of peri-implant soft tissue changes | Clinical evaluation of peri-implant soft tissue changes the Gingival Bleeding Time Index (GBTI). | 1 month after implantation and 4 months after implantation (just before prosthetic procedures) | 
| Clinical evaluation of peri-implant soft tissue changes | Clinical evaluation of peri-implant soft tissue changes the Width of keratinized tissue (WKT). | 1 month after implantation and 4 months after implantation (just before prosthetic procedures) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical evaluation | Biochemical evaluation of peri-implant sulcus fluid (PISF) total bacterial load. | 1 month after implantation and 4 months after implantation (just before prosthetic procedures) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Titanium, Customized Healing Abutment, PEEK, Peri-implant soft tissue, Dental implants, Esthetic Zone