PEEK Versus Titanium Customized Healing Abutments

NCT05989061 | Recruiting

• 1 other identifier: FDASU-RecIM122219
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implants

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Clinical evaluation of peri-implant soft tissue changes

  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

  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

  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

  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

  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 Outcomes (1)

• Biochemical evaluation

  1 month after implantation and 4 months after implantation (just before prosthetic procedures)

Study Arms (2)

PEEK customized healing abutment.

EXPERIMENTAL

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

Titanium customized healing abutment.

ACTIVE COMPARATOR

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

Interventions

PEEK customized healing abutment DEVICE

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

PEEK customized healing abutment.

Titanium customized healing abutment DEVICE

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

Titanium customized healing abutment.

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Poor oral hygiene condition.
• Pregnant and lactating females.
• Smokers.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ain Shams University

Cairo, Egypt

RECRUITING

Related Publications (25)

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  PMID: 26868927 BACKGROUND

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Study Officials

• Ahmed E. Amr, Assoc Prof

  Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Samar F. El Desouki, Master student

CONTACT

+201010876119; SamarFakhrEldin@dent.asu.edu.eg

Hadeel G. Al Malahy, Lecturer

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 14, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

EG (1)