Actively Recruiting

Phase Not Applicable
Age: 20Years - 50Years
All Genders
Healthy Volunteers
ID05989061

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

Led by Ain Shams University · Updated on 2024-06-04

26

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of customized healing abutments made from polyetheretherketone (PEEK) compared to traditional titanium healing abutments in patients receiving dental implants. The study aims to assess whether PEEK abutments, due to their biological and aesthetic properties, can better support peri-implant soft tissue healing with reduced plaque accumulation. This trial involves adult patients missing a tooth in the esthetic zone and receiving guided delayed implant surgery. Participants are randomly assigned to one of two groups. One group receives a customized PEEK healing abutment placed at the same time as the implant surgery, while the other group receives a customized titanium healing abutment under the same conditions. Both treatments use guided implant surgery for precise implant placement, and the customized abutments are designed to match the patient's gingival architecture to encourage optimal soft tissue healing. Throughout the study, researchers will monitor changes in the peri-implant soft tissue at 1 month and 4 months after implantation, before the prosthetic procedures. Clinical evaluations and biochemical tests will measure tissue health and bacterial load around the implant. Participants will be followed closely during these periods to observe healing progress and the effects of the different abutment materials on tissue condition.

CONDITIONS

Brief Title

PEEK Versus Titanium Customized Healing Abutments

Who Can Participate

Age: 20Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have no systemic diseases per Cornell Medical Index-Health Questionnaire
  • Both genders are eligible
  • Age between 20 and 50 years
  • Missing tooth in the front or premolar area suitable for standard implant without additional bone or soft tissue procedures
  • Implant primary stability with ISQ of 70 or higher
  • Buccolingual bone width of at least 6 mm
  • Mesiodistal space of at least 7 mm
  • Healthy neighboring teeth on both sides
  • At least 6 natural teeth remaining in the same arch
  • Mouth opening of 30 mm or more
  • Sufficient keratinized gum tissue
  • Thick gum tissue phenotype
Not Eligible

You will not qualify if you...

  • Poor oral hygiene
  • Pregnant or breastfeeding women
  • Smokers or tobacco users

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of implant surgery

Participants undergo guided delayed implant surgery with placement of a customized PEEK or Titanium healing abutment simultaneously.

1 visit (in-person)

Post-operative Follow-up

Duration - 4 months

Participants are monitored for peri-implant soft tissue healing and biochemical evaluation after implant placement.

Visits at 1 month and 4 months after implantation (in-person)

Trial Site Locations

Total: 1 location

1

Faculty of Dentistry Ain Shams University

Cairo, Egypt

Actively Recruiting

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Research Team

S

Samar F. El Desouki, Master student

H

Hadeel G. Al Malahy, Lecturer

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

The Predictive Value of Resonance Frequency Analysis Measurements in the Surgical Placement and Loading of Endosseous Implants.

Serge Baltayan, Joan Pi-Anfruns, Tara Aghaloo...

https://pubmed.ncbi.nlm.nih.gov/26917203

Peri-Implant Soft Tissue Conditioning by Means of Customized Healing Abutment: A Randomized Controlled Clinical Trial.

Mario Beretta, Pier Paolo Poli, Silvia Pieriboni...

https://pubmed.ncbi.nlm.nih.gov/31546800

Is it safe to reuse dental implant healing abutments sterilized and serviced by dealers of dental implant manufacturers? An in vitro sterility analysis.

Umut Cakan, Cagri Delilbasi, Sevda Er...

https://pubmed.ncbi.nlm.nih.gov/25706262

A prospective multicenter 5-year radiographic evaluation of crestal bone levels over time in 596 dental implants placed in 192 patients.

David L Cochran, Pirkka V Nummikoski, John D Schoolfield...

https://pubmed.ncbi.nlm.nih.gov/19405825

Guided Immediate Implant Placement with Wound Closure by Computer-Aided Design/Computer-Assisted Manufacture Sealing Socket Abutment: Case Report.

Gary Finelle, Sang J Lee

https://pubmed.ncbi.nlm.nih.gov/28291855