Clinical trial NCT05989061: PEEK Versus Titanium Customized Healing Abutments
Official title: PEEK Versus Titanium Customized Healing Abutments: Evaluation of Peri-implant Soft Tissues and Sulcus Fluid Bacterial Load
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implants
Keywords: Customized Healing Abutment
PEEK
Peri-implant soft tissue
Dental implants
Titanium
Esthetic Zone
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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?"

Eligibility criteria: Inclusion Criteria:

1. Patients should be systematically free from any disease as according to Cornell Medical Index-Health Questionnaire .
2. Both genders.
3. Age from 20-50 years.
4. Missing tooth in esthetic zone (Anterior/Premolar) to be restored with standard implant, with no need for additional bone and soft tissue augmentation procedures.
5. Implants primary stability ISQ ≥ 70 unites using the Osstell Mentor
6. BuccoLingual bone width ≥ 6 mm.
7. Mesio distal space ≥ 7 mm
8. Sound Mesial and distal neighboring teeth.
9. At least 6 natural teeth remaining in the same arch .
10. Mouth opening ≥ 30mm.
11. Enough keratinized mucosa.
12. Thick phenotype.

Exclusion Criteria:

1. Poor oral hygiene condition.
2. Pregnant and lactating females.
3. Smokers.

Primary outcomes:
measure: Clinical evaluation of peri-implant soft tissue changes
timeFrame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
measure: Clinical evaluation of peri-implant soft tissue changes
timeFrame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
measure: Clinical evaluation of peri-implant soft tissue changes
timeFrame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
measure: Clinical evaluation of peri-implant soft tissue changes
timeFrame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
measure: Clinical evaluation of peri-implant soft tissue changes
timeFrame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
Secondary outcomes:
measure: Biochemical evaluation
timeFrame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Ahmed E. Amr, Assoc Prof
role: STUDY_DIRECTOR
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