PEEK Versus Titanium Customized Healing Abutments: Evaluation of Peri-implant Soft Tissues and Sulcus Fluid Bacterial Load
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Clinical evaluation of peri-implant soft tissue changes
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
PEEK customized healing abutment.
Group I (Customized PEEK Healing Abutment):
13 patients will receive guided delayed implant and a customized PEEK healing abutment placed simultaneously with implant surgery
Intervention: PEEK customized healing abutment (Device)
Titanium customized healing abutment.
Group II (Customized Titanium Healing Abutment):
13 patients will receive guided delayed implant and a customized titanium healing abutment placed simultaneously with implant surgery.
Intervention: Titanium customized healing abutment (Device)
Outcomes
Primary Outcomes
Clinical evaluation of peri-implant soft tissue changes
Time Frame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
Clinical evaluation of peri-implant soft tissue changes the Probing Depth (PD).
Secondary Outcomes
- Biochemical evaluation(1 month after implantation and 4 months after implantation (just before prosthetic procedures))
Investigators
Samar El Desouki
Principal Investigator
Ain Shams University