PEEK Versus Titanium Customized Healing Abutments

August 10, 2023 updated by: Samar El Desouki, Ain Shams University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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?"

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: PEEK customized healing abutment
Guided delayed implant and a customized PEEK healing abutment placed simultaneously with implant surgery
Active Comparator: 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.
Device: Titanium customized healing abutment
Guided delayed implant and a customized Titanium healing abutment placed simultaneously with implant surgery

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Ahmed E. Amr, Assoc Prof, ain shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FDASU-RecIM122219

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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