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PEEK Versus Titanium Customized Healing Abutments

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05989061
Enrollment
26
Registered
2023-08-14
Start date
2023-09-01
Completion date
2024-10-31
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implants

Keywords

Customized Healing Abutment, PEEK, Peri-implant soft tissue, Dental implants, Titanium, Esthetic Zone

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?

Interventions

DEVICEPEEK customized healing abutment

Guided delayed implant and a customized PEEK healing abutment placed simultaneously with implant surgery

DEVICETitanium customized healing abutment

Guided delayed implant and a customized Titanium healing abutment placed simultaneously with implant surgery

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical evaluation of peri-implant soft tissue changes1 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

MeasureTime frameDescription
Biochemical evaluation1 month after implantation and 4 months after implantation (just before prosthetic procedures)Biochemical evaluation of peri-implant sulcus fluid (PISF) total bacterial load.

Countries

Egypt

Contacts

Primary ContactSamar F. El Desouki, Master student
SamarFakhrEldin@dent.asu.edu.eg+201010876119
Backup ContactHadeel G. Al Malahy, Lecturer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026